A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04969939
Collaborator
(none)
114
Enrollment
14
Locations
4
Arms
17.9
Anticipated Duration (Months)
8.1
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study is looking at a new medicine to help people lose weight. In this study participants will either get semaglutide and NNC0165-1875 or semaglutide and a "dummy" medicine (placebo). Which treatment participants get is decided by chance. Participants will get 2 injections per week, on the same day. Participants will have to take the study medicine by use of a pre-filled pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show participants how. The study will last for about 26 weeks. Participants will have 17 visits at the clinic with the study doctor. At 4 of the clinic visits participants cannot eat and drink (water is allowed until 2 hours prior to the visit) for 8 hours before the visit.Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period. Women who are able to become pregnant can participate if they agree to use contraception during the study.

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
  • Drug: Semaglutide 2.4 mg and placebo 2.0 mg
  • Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
  • Drug: Semaglutide 2.4 mg and placebo 1.0 mg
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
114 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo. Part 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.Part 1: is a 16-week study were one group of participants will receive two doses of NNC0165-1875 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo. Part 2: is a 40-week study were one group of participants will receive one dose of NNC0165 a week, in combination with one injection dose of semaglutide a week. The other group will receive a placebo.
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:
Investigation of Efficacy and Safety of NNC0165-1875 as add-on to Semaglutide for Weight Management in Subjects With Obesity
Actual Study Start Date :
Jul 15, 2021
Anticipated Primary Completion Date :
May 18, 2022
Anticipated Study Completion Date :
Jan 12, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg

Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg

Drug: Semaglutide 2.4 mg and NNC0165-1875 2.0 mg
NNC0165-1875 will be co-escalated once-weekly subcutaneously with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.

Placebo Comparator: Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg)

Participants will receive placebo as an add on to semaglutide 2.4 mg.

Drug: Semaglutide 2.4 mg and placebo 2.0 mg
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.

Experimental: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg

Participants will receive two doses of NNC0165-1875 as an add on to semaglutide s.c. 2.4 mg

Drug: Semaglutide 2.4 mg and NNC0165-1875 1.0 mg
NNC0165-1875 will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.

Placebo Comparator: Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg)

Participants will receive placebo as an add on to semaglutide 2.4 mg.

Drug: Semaglutide 2.4 mg and placebo 1.0 mg
NNC0165-1875 placebo will be co-escalated subcutaneously once-weekly with semaglutide every 2 weeks for the first 4 weeks, and every 4 weeks for the next 8 weeks until final target dose levels are reached.

Outcome Measures

Primary Outcome Measures

  1. Part 1: Number of treatment-emergent adverse events (TEAEs) [From time of dosing (day 1) to follow-up (week 24)]

    Number of events

  2. Part 2: Change in body weight [From randomisation (week 24) to end of treatment (week 40)]

    Percentage

Secondary Outcome Measures

  1. Part 2: Change in body weight [From randomisation (week 24) to end of treatment (week 40)]

    kg

  2. Part 2: Change in HbA1c [From randomisation (week 24) to end of treatment (week 40)]

    Percentage point

  3. Part 2: Change in fasting plasma glucose [From randomisation (week 24) to end of treatment (week 40)]

    mmol/l

  4. Part 2: Change in fasting insulin [From randomisation (week 24) to end of treatment (week 40)]

    pmol/l

  5. Part 2: Change in waist circumference [From randomisation (week 24) to end of treatment (week 40)]

    cm

  6. Part 2: Relative change in total cholesterol [From randomisation (week 24) to end of treatment (week 40)]

    ratio to baseline

  7. Part 2: Relative change in HDL cholesterol [From randomisation (week 24) to end of treatment (week 40)]

    ratio to baseline

  8. Part 2: Relative change in LDL cholesterol [From randomisation (week 24) to end of treatment (week 40)]

    ratio to baseline

  9. Part 2: Relative change in VLDL cholesterol [From randomisation (week 24) to end of treatment (week 40)]

    ratio to baseline

  10. Part 2: Relative change in Triglycerides [From randomisation (week 24) to end of treatment (week 40)]

    ratio to baseline

  11. Part 2: Relative change in Free fatty acids [From randomisation (week 24) to end of treatment (week 40)]

    ratio to baseline

  12. Part 2: Number of emergent adverse events (TEAEs) [From baseline at (week 0) to end of trial (week 48)]

    Count of events

  13. Part 2: Number of serious treatment emergent adverse events (SAEs) [From baseline at (week 0) to end of trial (week 48)]

    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:
  • Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.

  • Male or female, age above or equal to 18 years at the time of signing informed consent.

  • BMI 30.0 - 45.0 kg/m^2 (both inclusive) at the screening visit.

Exclusion Criteria:
  • HbA1c greater than or equal to 48 mmol/mol (6.5%) as measured by a central laboratory at screening.

  • History of type 1 or type 2 diabetes mellitus.

  • Treatment with glucose-lowering agent(s) within 90 days before screening.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteWalnut CreekCaliforniaUnited States94598
2Novo Nordisk Investigational SiteJacksonvilleFloridaUnited States32216
3Novo Nordisk Investigational SiteRoswellGeorgiaUnited States30076
4Novo Nordisk Investigational SiteHonoluluHawaiiUnited States96814
5Novo Nordisk Investigational SiteEvanstonIllinoisUnited States60201-2477
6Novo Nordisk Investigational SiteOverland ParkKansasUnited States66212
7Novo Nordisk Investigational SiteLouisvilleKentuckyUnited States40213
8Novo Nordisk Investigational SiteWilmingtonNorth CarolinaUnited States28401
9Novo Nordisk Investigational SiteCharlestonSouth CarolinaUnited States29425
10Novo Nordisk Investigational SiteNorth CharlestonSouth CarolinaUnited States29405
11Novo Nordisk Investigational SiteDallasTexasUnited States75226
12Novo Nordisk Investigational SiteSaint GeorgeUtahUnited States84790
13Novo Nordisk Investigational SiteNewport NewsVirginiaUnited States23606
14Novo Nordisk Investigational SiteRichmondVirginiaUnited States23294

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04969939
Other Study ID Numbers:
  • NN9775-4708
  • U1111-1254-9046
First Posted:
Jul 21, 2021
Last Update Posted:
Nov 19, 2021
Last Verified:
Nov 1, 2021
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 Nov 19, 2021