REIMAGINE 2: A Research Study to See How Well CagriSema Compared to Semaglutide, Cagrilintide and Placebo Lowers Blood Sugar and Body Weight in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06065540
Collaborator
(none)
2,700
332
7
27.6
8.1
0.3

Study Details

Study Description

Brief Summary

The study will look at how well CagriSema helps people lower their blood sugar and body weight. CagriSema is a new weekly medicine that combines two medicines called semaglutide and cagrilintide. CagriSema will be compared to the two medicines semaglutide and cagrilintide, when they are taken alone. CagriSema will also be compared to a "dummy" medicine without any active ingredient. The study will be done in participants who have type 2 diabetes. Participants will take the study medicine together with the current diabetes medicine (metformin with or without an SGLT2 inhibitor).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
2700 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. in Doses 2.4/2.4 mg and 1.0/1.0 mg Once Weekly Versus Semaglutide 2.4 mg and 1.0 mg, Cagrilintide 2.4 mg and Placebo in Participants With Type 2 Diabetes Inadequately Controlled on Metformin With or Without an SGLT2 Inhibitor
Anticipated Study Start Date :
Sep 27, 2023
Anticipated Primary Completion Date :
Nov 26, 2025
Anticipated Study Completion Date :
Jan 14, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: CagriSema 2.4 mg/2.4 mg

Participants will receive once-weekly subcutaneous (s.c) injections of 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Drug: Cagrilintide
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of cagrilintide is reached.

Drug: Semaglutide
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.

Experimental: CagriSema 1.0 mg/1.0 mg

Participants will receive once-weekly s.c injections of 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.

Drug: Cagrilintide
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of cagrilintide is reached.

Drug: Semaglutide
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.

Active Comparator: Semaglutide 2.4 mg

Participants will receive once-weekly s.c injection of 2.4 mg semaglutide for 68 weeks.

Drug: Semaglutide
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.

Active Comparator: Semaglutide 1.0 mg

Participants will receive once-weekly s.c injection of 1.0 mg semaglutide for 68 weeks.

Drug: Semaglutide
Participants will receive once-weekly s.c injection of semaglutide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of semaglutide is reached.

Active Comparator: Cagrilintide 2.4 mg

Participants will receive once-weekly s.c injection of 2.4 mg cagrilintide for 68 weeks.

Drug: Cagrilintide
Participants will receive once-weekly s.c injection of cagrilintide at escalating doses every week until maintenance dose of 2.4 mg and 1.0 mg of cagrilintide is reached.

Placebo Comparator: Placebo 2.4 mg/2.4 mg

Participants will receive once-weekly s.c injection of placebo matched to 2.4 mg cagrilintide and 2.4 mg semaglutide for 68 weeks.

Drug: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.

Drug: Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.

Placebo Comparator: Placebo 1.0 mg/1.0 mg

Participants will receive once-weekly s.c injection of placebo matched to 1.0 mg cagrilintide and 1.0 mg semaglutide for 68 weeks.

Drug: Placebo cagrilintide
Participants will receive placebo matched to cagrilintide subcutaneously.

Drug: Placebo semaglutide
Participants will receive placebo matched to semaglutide subcutaneously.

Outcome Measures

Primary Outcome Measures

  1. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Change in glycated haemoglobin (HbA1c) [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage-points.

  2. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Relative change in body weight [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage.

Secondary Outcome Measures

  1. CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: Change in HbA1c [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage-points.

  2. CagriSema 2.4 mg/2.4 mg versus cagrilintide 2.4 mg: Relative change in body weight [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage.

  3. CagriSema 2.4 mg/2.4 mg versus semaglutide 1.0 mg: Change in HbA1c [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage-points.

  4. CagriSema 2.4 mg/2.4 mg versus semaglutide 1.0 mg: Relative change in body weight [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage.

  5. Cagrilintide 2.4 mg versus placebo: Change in HbA1c [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage-points.

  6. Cagrilintide 2.4 mg versus placebo: Relative change in body weight [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage.

  7. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of greater than or equal to (>=) 10 percent (%) weight reduction [From baseline (week 0) to end of treatment (week 68)]

    Measured as count of participants.

  8. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of >= 15 % weight reduction [From baseline (week 0) to end of treatment (week 68)]

    Measured as count of participants.

  9. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of >= 20 % weight reduction [From baseline (week 0) to end of treatment (week 68)]

    Measured as count of participants.

  10. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time in Tight Target Range (TITR) 3.9-7.8 millimoles per litre (mmol/L) (70-140 milligrams per decilitre [mg/dL]) [From baseline (week -3) to end of treatment (week 68)]

    Measured in percentage-points.

  11. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Systolic Blood Pressure (SBP) [From baseline (week 0) to end of treatment (week 68)]

    Measured in millimeters of mercury (mmHg).

  12. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in triglycerides [From baseline (week 0) to end of treatment (week 68)]

    Measured as ratio of triglycerides.

  13. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in non-High Density Lipoprotein (HDL) cholesterols [From baseline (week 0) to end of treatment (week 68)]

    Measured as ratio of non-HDL cholesterol.

  14. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in Time In Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) [From baseline (week -3) to end of treatment (week 68)]

    Measured in percentage-points.

  15. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP) [From baseline (week 0) to end of treatment (week 68)]

    Measured as ratio of hsCRP.

  16. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Fasting Plasma Glucose (FPG) [From baseline (week 0) to end of treatment (week 68)]

    Measured in mmol/L.

  17. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of HbA1c target values of less than (<) 7.0% (<53 millimoles per mole [mmol/mol]) [At end of treatment (week 68)]

    Measured as count of participants.

  18. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Achievement of HbA1c target values of less than or equal to (≤)6.5% (≤48 mmol/mol) [At end of treatment (week 68)]

    Measured as count of participants.

  19. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time above range, >10.0 mmol/L (>180 mg/dL) [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage-points.

  20. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Change in time above range, >13.9 mmol/L (>250 mg/dL) [From baseline (week 0) to end of treatment (week 68)]

    Measured in percentage-points.

  21. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): CGM - Within-day glycaemic variability (% coefficient of variation [CV]) [At end of treatment (week 68)]

    Measured in percentage.

  22. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg versus 1.0 mg): Achievement of ≥ 5 % weight reduction [From baseline (week 0) to end of treatment (week 68)]

    Measured as count of participants.

  23. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in waist circumference [From baseline (week 0) to end of treatment (week 68)]

    Measured in centimetre.

  24. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Diastolic Blood Pressure (DBP) [From baseline (week 0) to end of treatment (week 68)]

    Measured in mmHg.

  25. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in total cholesterol [From baseline (week 0) to end of treatment (week 68)]

    Measured as ratio of total cholesterol.

  26. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in HDL cholesterol [From baseline (week 0) to end of treatment (week 68)]

    Measured as ratio of HDL cholesterol.

  27. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in low-density lipoprotein (LDL) cholesterol [From baseline (week 0) to end of treatment (week 68)]

    Measured as ratio of LDL cholesterol.

  28. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in very low-density lipoprotein (VLDL) cholesterol [From baseline (week 0) to end of treatment (week 68)]

    Measured as ratio of VLDL.

  29. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Ratio to baseline in free fatty acids [From baseline (week 0) to end of treatment (week 68)]

    Measured as ratio of free fatty acids.

  30. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Short Form (SF)-36v score- Physical component summary score [From baseline (week 0) to end of treatment (week 68)]

    SF-36v2 measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an standard deviation of 10. Physical component summary score range from 6.1 to 79.7, with higher scores indicating better functional health and well-being.

  31. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in SF-36v2 score- Mental component summary score [From baseline (week 0) to end of treatment (week 68)]

    SF-36v2 measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 acute scores are norm-based scores, i.e. transformed to a scale where the 2009 US general population has a mean of 50 and an standard deviation of 10. Mental component summary score range from -3.8 to 78.7, with higher scores indicating better functional health and well-being.

  32. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score [From baseline (week 0) to end of treatment (week 68)]

    DTSQc measures treatment satisfaction and diabetes-specific quality of life (QoL). The measure consists of 8 items yielding 1 global score and 2 single item scores. Total treatment satisfaction scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control.

  33. CagriSema versus semaglutide (2.4 mg/2.4 mg versus 2.4 mg and 1.0 mg/1.0 mg vs 1.0 mg): Change in Treatment Related Impact Measure for Diabetes (TRIM-D) score [From baseline (week 0) to end of treatment (week 68)]

    TRIM-D measures impact of diabetes treatment. The measure consists of 28 items yielding 5 domain scores and a total score. The scores were transformed to a 0-100 scale with higher scores indicating a better health state.

  34. CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of treatment emergent adverse events (TEAEs) [From baseline (week 0) to end of study (week 75)]

    Measured as count of events.

  35. CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) [From baseline (week 0) to end of study (week 75)]

    Measured as count of episodes.

  36. CagriSema (2.4 mg/2.4 mg and 1.0 mg/1.0 mg) versus semaglutide (2.4 mg and 1.0 mg), placebo and cagrilintide 2.4 mg: Number of severe hypoglycaemic episodes (level 3) [From baseline (week 0) to end of study (week 75)]

    Measured as count of episodes. Hypoglycaemia episodes (level 3) are the episodes associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male or female.

  • Age 18 years or above at the time of signing the informed consent.

  • Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days before screening.

  • Stable daily dose(s) greater than or equal to 90 days before screening of any of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without Sodium-Glucose Cotransporter-2 (SGLT2) inhibitors.

  • Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole [mmol/mol]) (both inclusive) as determined by central laboratory at screening.

  • Body Mass Index (BMI) greater than or equal to 25 kilogram per square metre ( kg/m^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion Criteria:
  • Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square metre (mL/min/1.73 m^2) as determined by central laboratory at screening.

  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed.

  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Birmingham Alabama United States 35211
2 Novo Nordisk Investigational Site Birmingham Alabama United States 35294
3 Novo Nordisk Investigational Site Pelham Alabama United States 35124
4 Novo Nordisk Investigational Site Phoenix Arizona United States 85006
5 Novo Nordisk Investigational Site Phoenix Arizona United States 85020
6 Novo Nordisk Investigational Site Little Rock Arkansas United States 72205
7 Novo Nordisk Investigational Site Banning California United States 92220
8 Novo Nordisk Investigational Site Chula Vista California United States 91911
9 Novo Nordisk Investigational Site Concord California United States 94520
10 Novo Nordisk Investigational Site Escondido California United States 92025
11 Novo Nordisk Investigational Site Gardena California United States 90247
12 Novo Nordisk Investigational Site La Mesa California United States 91942
13 Novo Nordisk Investigational Site Loma Linda California United States 92354
14 Novo Nordisk Investigational Site Mission Hills California United States 91345
15 Novo Nordisk Investigational Site Palm Springs California United States 92262
16 Novo Nordisk Investigational Site Panorama City California United States 91402
17 Novo Nordisk Investigational Site San Diego California United States 92111
18 Novo Nordisk Investigational Site Santa Ana California United States 92704
19 Novo Nordisk Investigational Site Toluca Lake California United States 91602
20 Novo Nordisk Investigational Site Colorado Springs Colorado United States 80906
21 Novo Nordisk Investigational Site Jacksonville Florida United States 32204
22 Novo Nordisk Investigational Site Miami Florida United States 33144
23 Novo Nordisk Investigational Site Miami Florida United States 33155
24 Novo Nordisk Investigational Site Miami Florida United States 33165
25 Novo Nordisk Investigational Site Ocoee Florida United States 34761
26 Novo Nordisk Investigational Site Orange City Florida United States 32763
27 Novo Nordisk Investigational Site Orlando Florida United States 32804
28 Novo Nordisk Investigational Site Orlando Florida United States 32806
29 Novo Nordisk Investigational Site Oviedo Florida United States 32765
30 Novo Nordisk Investigational Site Pembroke Pines Florida United States 33027
31 Novo Nordisk Investigational Site Conyers Georgia United States 30094
32 Novo Nordisk Investigational Site Macon Georgia United States 31210
33 Novo Nordisk Investigational Site Marietta Georgia United States 30067
34 Novo Nordisk Investigational Site Roswell Georgia United States 30076
35 Novo Nordisk Investigational Site Honolulu Hawaii United States 96813
36 Novo Nordisk Investigational Site Boise Idaho United States 83702
37 Novo Nordisk Investigational Site Meridian Idaho United States 83646
38 Novo Nordisk Investigational Site Chicago Illinois United States 60607
39 Novo Nordisk Investigational Site Gurnee Illinois United States 60031
40 Novo Nordisk Investigational Site Skokie Illinois United States 60077
41 Novo Nordisk Investigational Site West Des Moines Iowa United States 50265
42 Novo Nordisk Investigational Site Newton Kansas United States 67114
43 Novo Nordisk Investigational Site Topeka Kansas United States 66606
44 Novo Nordisk Investigational Site Lafayette Louisiana United States 70508
45 Novo Nordisk Investigational Site New Bedford Massachusetts United States 02740
46 Novo Nordisk Investigational Site Gulfport Mississippi United States 39503
47 Novo Nordisk Investigational Site Chesterfield Missouri United States 63017
48 Novo Nordisk Investigational Site Trenton New Jersey United States 08611
49 Novo Nordisk Investigational Site Albuquerque New Mexico United States 87107
50 Novo Nordisk Investigational Site Albany New York United States 12203
51 Novo Nordisk Investigational Site East Syracuse New York United States 13057
52 Novo Nordisk Investigational Site West Seneca New York United States 14224
53 Novo Nordisk Investigational Site Westfield New York United States 14787
54 Novo Nordisk Investigational Site Chapel Hill North Carolina United States 27514
55 Novo Nordisk Investigational Site Greensboro North Carolina United States 27408
56 Novo Nordisk Investigational Site Morehead City North Carolina United States 28557
57 Novo Nordisk Investigational Site Statesville North Carolina United States 28625
58 Novo Nordisk Investigational Site Wilmington North Carolina United States 28401
59 Novo Nordisk Investigational Site Dublin Ohio United States 43016
60 Novo Nordisk Investigational Site Norman Oklahoma United States 73069
61 Novo Nordisk Investigational Site Cumberland Rhode Island United States 02864
62 Novo Nordisk Investigational Site East Greenwich Rhode Island United States 02818
63 Novo Nordisk Investigational Site Anderson South Carolina United States 29621
64 Novo Nordisk Investigational Site Gaffney South Carolina United States 29340
65 Novo Nordisk Investigational Site Simpsonville South Carolina United States 29681-1538
66 Novo Nordisk Investigational Site Spartanburg South Carolina United States 29303
67 Novo Nordisk Investigational Site Bristol Tennessee United States 37620-7352
68 Novo Nordisk Investigational Site Kingsport Tennessee United States 37660
69 Novo Nordisk Investigational Site Nashville Tennessee United States 37203
70 Novo Nordisk Investigational Site Arlington Texas United States 76012-4637
71 Novo Nordisk Investigational Site Bellaire Texas United States 77401
72 Novo Nordisk Investigational Site Cedar Park Texas United States 78613
73 Novo Nordisk Investigational Site Dallas Texas United States 75230
74 Novo Nordisk Investigational Site Dallas Texas United States 75231
75 Novo Nordisk Investigational Site Dallas Texas United States 75234
76 Novo Nordisk Investigational Site Houston Texas United States 77040
77 Novo Nordisk Investigational Site Houston Texas United States 77061
78 Novo Nordisk Investigational Site Houston Texas United States 77079
79 Novo Nordisk Investigational Site Katy Texas United States 77450
80 Novo Nordisk Investigational Site Kerrville Texas United States 78028
81 Novo Nordisk Investigational Site San Antonio Texas United States 78229
82 Novo Nordisk Investigational Site San Antonio Texas United States 78233
83 Novo Nordisk Investigational Site Shavano Park Texas United States 78231
84 Novo Nordisk Investigational Site Tomball Texas United States 77375
85 Novo Nordisk Investigational Site Sandy Utah United States 84093
86 Novo Nordisk Investigational Site West Jordan Utah United States 84088
87 Novo Nordisk Investigational Site Newport News Virginia United States 23606
88 Novo Nordisk Investigational Site Renton Washington United States 98057
89 Novo Nordisk Investigational Site Green Bay Wisconsin United States 54303
90 Novo Nordisk Investigational Site Caba Buenos Aires Argentina C1128 AAF
91 Novo Nordisk Investigational Site Buenos Aires Argentina C1023AAB
92 Novo Nordisk Investigational Site Buenos Aires Argentina C1425AGC
93 Novo Nordisk Investigational Site Caba Argentina C1119ACN
94 Novo Nordisk Investigational Site Caba Argentina C1180AAX
95 Novo Nordisk Investigational Site Rosario Argentina S2000CUD
96 Novo Nordisk Investigational Site Camperdown New South Wales Australia 2050
97 Novo Nordisk Investigational Site Darlinghurst New South Wales Australia 2010
98 Novo Nordisk Investigational Site Merewether New South Wales Australia 2291
99 Novo Nordisk Investigational Site Meadowbrook Queensland Australia 4131
100 Novo Nordisk Investigational Site Oaklands Park South Australia Australia 5046
101 Novo Nordisk Investigational Site Fitzroy Victoria Australia 3065
102 Novo Nordisk Investigational Site Melbourne Victoria Australia 3004
103 Novo Nordisk Investigational Site Curitiba Parana Brazil 80030-480
104 Novo Nordisk Investigational Site São Paulo Sao Paulo Brazil 01228-000
105 Novo Nordisk Investigational Site São Paulo Sao Paulo Brazil 01228-200
106 Novo Nordisk Investigational Site Burgas Bulgaria 8000
107 Novo Nordisk Investigational Site Gotse Delchev Bulgaria 2900
108 Novo Nordisk Investigational Site Kardzhali Bulgaria 6600
109 Novo Nordisk Investigational Site Lom Bulgaria 3600
110 Novo Nordisk Investigational Site Razgrad Bulgaria 7200
111 Novo Nordisk Investigational Site Sofia Bulgaria 1202
112 Novo Nordisk Investigational Site Sofia Bulgaria 1756
113 Novo Nordisk Investigational Site Varna Bulgaria 9000
114 Novo Nordisk Investigational Site Varna Bulgaria 9010
115 Novo Nordisk Investigational Site Calgary Alberta Canada T2H 2G4
116 Novo Nordisk Investigational Site Sherwood Park Alberta Canada T8H 0N2
117 Novo Nordisk Investigational Site Surrey British Columbia Canada V3Z 2N6
118 Novo Nordisk Investigational Site Moncton New Brunswick Canada E1G 1A7
119 Novo Nordisk Investigational Site Barrie Ontario Canada L4N 7L3
120 Novo Nordisk Investigational Site Brampton Ontario Canada L6S 0C6
121 Novo Nordisk Investigational Site Concord Ontario Canada L4K 4M2
122 Novo Nordisk Investigational Site Etobicoke Ontario Canada M9R 4E1
123 Novo Nordisk Investigational Site London Ontario Canada N5W 6A2
124 Novo Nordisk Investigational Site Markham Ontario Canada L3P 7P2
125 Novo Nordisk Investigational Site Nepean Ontario Canada K2J 0V2
126 Novo Nordisk Investigational Site Oshawa Ontario Canada L1G4T3
127 Novo Nordisk Investigational Site Oshawa Ontario Canada L1J 2K9
128 Novo Nordisk Investigational Site Toronto Ontario Canada M4G 3E8
129 Novo Nordisk Investigational Site Toronto Ontario Canada M6G 1M2
130 Novo Nordisk Investigational Site Montreal Quebec Canada H4N 2W2
131 Novo Nordisk Investigational Site Pointe-Claire Quebec Canada H9R 4S3
132 Novo Nordisk Investigational Site Saint-Laurent Quebec Canada H4T 1Z9
133 Novo Nordisk Investigational Site Sherbrooke Quebec Canada J1J 2G2
134 Novo Nordisk Investigational Site Terrebonne Quebec Canada J6X 4P7
135 Novo Nordisk Investigational Site Quebec Canada G1V 4W2
136 Novo Nordisk Investigational Site Nanjing Jiangsu China 210011
137 Novo Nordisk Investigational Site Suzhou Jiangsu China 215002
138 Novo Nordisk Investigational Site Barranquilla Colombia 80001
139 Novo Nordisk Investigational Site Bucaramange Colombia 681007
140 Novo Nordisk Investigational Site Cali Colombia 760042
141 Novo Nordisk Investigational Site Monteria Colombia 230001
142 Novo Nordisk Investigational Site Zagreb Grad Zagreb Croatia 10000
143 Novo Nordisk Investigational Site Osijek Osječko - Baranjska Županija Croatia 31000
144 Novo Nordisk Investigational Site Rijeka Primorsko - Goranska Županija Croatia 51 000
145 Novo Nordisk Investigational Site Opatija Croatia 51 410
146 Novo Nordisk Investigational Site Slavonski Brod Croatia 35 000
147 Novo Nordisk Investigational Site Varazdin Croatia 42 000
148 Novo Nordisk Investigational Site Praha 4 Czech Republic Czechia 140 21
149 Novo Nordisk Investigational Site Brno Czechia 602 00
150 Novo Nordisk Investigational Site Broumov Czechia 550 01
151 Novo Nordisk Investigational Site Holešov Czechia 76901
152 Novo Nordisk Investigational Site Plzeň 3 Czechia 301 00
153 Novo Nordisk Investigational Site Praha 1 Czechia 110 00
154 Novo Nordisk Investigational Site Praha 4 Czechia 140 00
155 Novo Nordisk Investigational Site Aarhus N Denmark 8200
156 Novo Nordisk Investigational Site Herlev Denmark 2730
157 Novo Nordisk Investigational Site Hillerød Denmark 3400
158 Novo Nordisk Investigational Site Hvidovre Denmark 2650
159 Novo Nordisk Investigational Site København Denmark 2400
160 Novo Nordisk Investigational Site Odense C Denmark 5000
161 Novo Nordisk Investigational Site Jyväskylä Finland 40100
162 Novo Nordisk Investigational Site Seinäjoki Finland 60220
163 Novo Nordisk Investigational Site Tampere Finland 33100
164 Novo Nordisk Investigational Site Turku Finland 20520
165 Novo Nordisk Investigational Site Berlin Germany 13597
166 Novo Nordisk Investigational Site Daaden Germany 57567
167 Novo Nordisk Investigational Site Dortmund Germany 44137
168 Novo Nordisk Investigational Site Dresden Germany 01307
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170 Novo Nordisk Investigational Site Essen Germany 45136
171 Novo Nordisk Investigational Site Gelnhausen Germany 63571
172 Novo Nordisk Investigational Site Hamburg Germany 21109
173 Novo Nordisk Investigational Site Hamburg Germany 22041
174 Novo Nordisk Investigational Site Lingen Germany 49808
175 Novo Nordisk Investigational Site Ludwigshafen Germany 67059
176 Novo Nordisk Investigational Site Lübeck Germany 23562
177 Novo Nordisk Investigational Site München Germany 81667
178 Novo Nordisk Investigational Site Oldenburg in Holstein Germany 23758
179 Novo Nordisk Investigational Site Zwenkau Germany 04442
180 Novo Nordisk Investigational Site Nea Efkarpia Thessaloniki Greece 56429
181 Novo Nordisk Investigational Site Athens Greece 115 25
182 Novo Nordisk Investigational Site Athens Greece GR-11527
183 Novo Nordisk Investigational Site Athens Greece GR-15125
184 Novo Nordisk Investigational Site Haidari-Athens Greece GR-12462
185 Novo Nordisk Investigational Site Larissa Greece GR-41110
186 Novo Nordisk Investigational Site Thessaloniki Greece 54636
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188 Novo Nordisk Investigational Site Thessaloniki Greece GR-54642
189 Novo Nordisk Investigational Site Thessaloniki Greece GR-54643
190 Novo Nordisk Investigational Site Szeged Csongrád-Csanád Hungary H-6725
191 Novo Nordisk Investigational Site Debrecen Hajdu-Bihar Hungary 4032
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232 Novo Nordisk Investigational Site Ibaraki Japan 311-0113
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236 Novo Nordisk Investigational Site Bucheon-si Gyeonggi-do Korea, Republic of 14647
237 Novo Nordisk Investigational Site Daegu Korea, Republic of 42415
238 Novo Nordisk Investigational Site Gwangju Korea, Republic of 501-717
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243 Novo Nordisk Investigational Site Mexicali Baja California Mexico 21200
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247 Novo Nordisk Investigational Site Lodz Lodzkie Poland 93-513
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249 Novo Nordisk Investigational Site Warszawa Mazovian Voivodeship Poland 02-117
250 Novo Nordisk Investigational Site Bialystok Podlaskie Poland 15-435
251 Novo Nordisk Investigational Site Bialystok Poland 15-351
252 Novo Nordisk Investigational Site Chrzanow Poland 32-500
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254 Novo Nordisk Investigational Site Gorzow Wielkopolski Poland 66-400
255 Novo Nordisk Investigational Site Lublin Poland 20-362
256 Novo Nordisk Investigational Site Pulawy Poland 24-100
257 Novo Nordisk Investigational Site Rzeszow Poland 35-055
258 Novo Nordisk Investigational Site Tychy Poland 43-100
259 Novo Nordisk Investigational Site Zgierz Poland 95-100
260 Novo Nordisk Investigational Site Staszow Świętokrzyskie Poland 28-200
261 Novo Nordisk Investigational Site Pitesti Arges Romania 110283
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265 Novo Nordisk Investigational Site Bacau Romania 600154
266 Novo Nordisk Investigational Site Brasov Romania 500283
267 Novo Nordisk Investigational Site Bucharest Romania 020475
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277 Novo Nordisk Investigational Site Bardejov Slovakia 08501
278 Novo Nordisk Investigational Site Kosice Slovakia 040 01
279 Novo Nordisk Investigational Site Malacky Slovakia 90101
280 Novo Nordisk Investigational Site Presov Slovakia 080 01
281 Novo Nordisk Investigational Site Prievidza Slovakia 971 01
282 Novo Nordisk Investigational Site Ruzomberok Slovakia 034 01
283 Novo Nordisk Investigational Site Sabinov Slovakia 083 01
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285 Novo Nordisk Investigational Site Trebisov Slovakia 075 01
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298 Novo Nordisk Investigational Site Pretoria Gauteng South Africa 0186
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300 Novo Nordisk Investigational Site Barcelona Spain 08035
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305 Novo Nordisk Investigational Site Segovia Spain 40002
306 Novo Nordisk Investigational Site Sevilla Spain 41010
307 Novo Nordisk Investigational Site Valencia Spain 46026
308 Novo Nordisk Investigational Site Lund Sweden 221 85
309 Novo Nordisk Investigational Site Lund Sweden 222 21
310 Novo Nordisk Investigational Site Malmö Sweden 205 02
311 Novo Nordisk Investigational Site Stockholm Sweden 171 76
312 Novo Nordisk Investigational Site Örebro Sweden 701 85
313 Novo Nordisk Investigational Site Adana Turkey 01130
314 Novo Nordisk Investigational Site Antalya Turkey 07058
315 Novo Nordisk Investigational Site Eskisehir Turkey 26040
316 Novo Nordisk Investigational Site Istanbul Turkey 34098
317 Novo Nordisk Investigational Site Istanbul Turkey 34371
318 Novo Nordisk Investigational Site Istanbul Turkey 34390
319 Novo Nordisk Investigational Site Istanbul Turkey 34480
320 Novo Nordisk Investigational Site Istanbul Turkey 34722
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322 Novo Nordisk Investigational Site Stevenage Hertfordshire United Kingdom SG1 4AB
323 Novo Nordisk Investigational Site Bath United Kingdom BA2 3HT
324 Novo Nordisk Investigational Site Blackburn United Kingdom BB2 1AX
325 Novo Nordisk Investigational Site Dundee United Kingdom DD1 9SY
326 Novo Nordisk Investigational Site Foresterhill United Kingdom AB25 2ZP
327 Novo Nordisk Investigational Site Liverpool United Kingdom L9 7AL
328 Novo Nordisk Investigational Site Norwich United Kingdom NR4 7UY
329 Novo Nordisk Investigational Site Pickering United Kingdom YO18 8BL
330 Novo Nordisk Investigational Site Southampton United Kingdom SO30 3JB
331 Novo Nordisk Investigational Site Swansea United Kingdom SA2 8PP
332 Novo Nordisk Investigational Site Truro United Kingdom TR1 3LJ

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT06065540
Other Study ID Numbers:
  • NN9388-4896
  • U1111-1283-0427
  • 2022-502678-18
First Posted:
Oct 4, 2023
Last Update Posted:
Oct 4, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 4, 2023