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A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06131437
Collaborator
(none)
800
Enrollment
45
Locations
2
Arms
22.8
Anticipated Duration (Months)
17.8
Patients Per Site
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Efficacy and Safety of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15 mg s.c. Once-weekly in Participants With Obesity
Anticipated Study Start Date :
Nov 15, 2023
Anticipated Primary Completion Date :
Aug 27, 2025
Anticipated Study Completion Date :
Oct 8, 2025

Arms and Interventions

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

Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 72 weeks.

Drug: Cagrilintide
Cagrilintide will be administered subcutaneously.

Drug: Semaglutide
Semaglutide will be administered subcutaneously.
Active Comparator: Tirzepatide 15 mg

Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 72 weeks.

Drug: Tirzepatide
Tirzepatide will be administered subcutaneously.

Outcome Measures

Primary Outcome Measures

  1. Relative change in body weight [From baseline (week 0) to end of treatment (week 72)]

    Measured in percentage (%).

Secondary Outcome Measures

  1. Achievement of greater than or equal to (≥) 25% weight reduction [From baseline (week 0) to end of treatment (week 72)]

    Count of participant.

  2. Achievement of ≥ 30% weight reduction [From baseline (week 0) to end of treatment (week 72)]

    Count of participant.

  3. Change in waist circumference [From baseline (week 0) to end of treatment (week 72)]

    Measured in centimeter (cm).

  4. Change in systolic blood pressure (SBP) [From baseline (week 0) to end of treatment (week 72)]

    Measured in millimeter of mercury (mmHg).

  5. Change in diastolic blood pressure (DBP) [From baseline (week 0) to end of treatment (week 72)]

    Measured in mmHg.

  6. Relative change in lipids: Total cholesterol [From baseline (week 0) to end of treatment (week 72)]

    Measured in percentage.

  7. Relative change in lipids: High-density lipoprotein (HDL) cholesterol [From baseline (week 0) to end of treatment (week 72)]

    Measured in percentage.

  8. Relative change in lipids: Non-HDL cholesterol [From baseline (week 0) to end of treatment (week 72)]

    Measured in percentage.

  9. Relative change in lipids: Low-density lipoprotein (LDL) cholesterol [From baseline (week 0) to end of treatment (week 72)]

    Measured in percentage.

  10. Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol [From baseline (week 0) to end of treatment (week 72)]

    Measured in percentage.

  11. Relative change in lipids: Triglycerides [From baseline (week 0) to end of treatment (week 72)]

    Measured in percentage.

  12. Number of Treatment-emergent Adverse Events (TEAEs) [From baseline (week 0) to end of study (week 78)]

    Count of events.

  13. Number of Treatment Emergent Serious adverse events (TESAEs) [From baseline (week 0) to end of study (week 78)]

    Count of events.

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

  • Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2)

Exclusion Criteria:

  • Glycated haemoglobin (HbA1c) ≥ 6.5 % (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening

  • History of type 1 or type 2 diabetes mellitus

Contacts and Locations

Locations

Site City State Country Postal Code
1 Novo Nordisk Investigational Site Birmingham Alabama United States 35294
2 Novo Nordisk Investigational Site Montgomery Alabama United States 36106
3 Novo Nordisk Investigational Site Costa Mesa California United States 92627
4 Novo Nordisk Investigational Site Walnut Creek California United States 94598
5 Novo Nordisk Investigational Site Aurora Colorado United States 80045
6 Novo Nordisk Investigational Site New Haven Connecticut United States 06510
7 Novo Nordisk Investigational Site Fleming Island Florida United States 32003
8 Novo Nordisk Investigational Site Jacksonville Florida United States 32216
9 Novo Nordisk Investigational Site Miramar Florida United States 33027
10 Novo Nordisk Investigational Site Conyers Georgia United States 30094
11 Novo Nordisk Investigational Site Honolulu Hawaii United States 96814
12 Novo Nordisk Investigational Site Chicago Illinois United States 60640
13 Novo Nordisk Investigational Site Skokie Illinois United States 60077
14 Novo Nordisk Investigational Site Indianapolis Indiana United States 46260
15 Novo Nordisk Investigational Site Buckley Michigan United States 49620
16 Novo Nordisk Investigational Site Saint Peters Missouri United States 63303
17 Novo Nordisk Investigational Site New York New York United States 10021
18 Novo Nordisk Investigational Site Chapel Hill North Carolina United States 27514
19 Novo Nordisk Investigational Site Greensboro North Carolina United States 27405
20 Novo Nordisk Investigational Site Greensboro North Carolina United States 27408
21 Novo Nordisk Investigational Site Raleigh North Carolina United States 27609
22 Novo Nordisk Investigational Site Wilmington North Carolina United States 28401
23 Novo Nordisk Investigational Site Wadsworth Ohio United States 44281
24 Novo Nordisk Investigational Site Norman Oklahoma United States 73072
25 Novo Nordisk Investigational Site Philadelphia Pennsylvania United States 19104-3317
26 Novo Nordisk Investigational Site Cumberland Rhode Island United States 02864
27 Novo Nordisk Investigational Site Charleston South Carolina United States 29425
28 Novo Nordisk Investigational Site North Charleston South Carolina United States 29405
29 Novo Nordisk Investigational Site Simpsonville South Carolina United States 29681-1538
30 Novo Nordisk Investigational Site Spartanburg South Carolina United States 29303
31 Novo Nordisk Investigational Site Bristol Tennessee United States 37620
32 Novo Nordisk Investigational Site Kingsport Tennessee United States 37660
33 Novo Nordisk Investigational Site Amarillo Texas United States 79106
34 Novo Nordisk Investigational Site Austin Texas United States 78704
35 Novo Nordisk Investigational Site Bellaire Texas United States 77401
36 Novo Nordisk Investigational Site Dallas Texas United States 75226
37 Novo Nordisk Investigational Site Dallas Texas United States 75230
38 Novo Nordisk Investigational Site Dallas Texas United States 75390
39 Novo Nordisk Investigational Site Longview Texas United States 75605
40 Novo Nordisk Investigational Site Arlington Virginia United States 22206
41 Novo Nordisk Investigational Site Newport News Virginia United States 23606
42 Novo Nordisk Investigational Site Richmond Virginia United States 23294
43 Novo Nordisk Investigational Site Winchester Virginia United States 22601
44 Novo Nordisk Investigational Site Olympia Washington United States 98502
45 Novo Nordisk Investigational Site Renton Washington United States 98057

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:
NCT06131437
Other Study ID Numbers:
  • NN9838-7832
  • U1111-1292-4835
First Posted:
Nov 14, 2023
Last Update Posted:
Nov 14, 2023
Last Verified:
Nov 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:
Obesity
Tirzepatide

Study Results

No Results Posted as of Nov 14, 2023