A Research Study to Investigate How Well NNC0165-1875 in Combination With Semaglutide Works in People With Obesity
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT04969939
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 120
- 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.
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Semaglutide 2.4 mg and placebo 2.0 mg(NNC0165-1875 2.0 mg) Semaglutide 2.4 mg and placebo 2.0 mg Participants will receive placebo as an add on to semaglutide 2.4 mg. Semaglutide 2.4 mg and NNC0165-1875 1.0 mg 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 Semaglutide 2.4 mg and placebo 1.0 mg(NNC0165-1875 1.0 mg) Semaglutide 2.4 mg and placebo 1.0 mg Participants will receive placebo as an add on to semaglutide 2.4 mg. Semaglutide 2.4 mg and NNC0165-1875 2.0 mg 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
- Primary Outcome Measures
Name Time Method Part 1: Number of treatment-emergent adverse events (TEAEs) From time of dosing (day 1) to follow-up (week 24) Number of events
Part 2: Change in body weight From randomisation (week 24) to end of treatment (week 40) Percentage
- Secondary Outcome Measures
Name Time Method Part 2: Change in fasting insulin From randomisation (week 24) to end of treatment (week 40) pmol/l
Part 2: Relative change in Free fatty acids From randomisation (week 24) to end of treatment (week 40) ratio to baseline
Part 2: Relative change in HDL cholesterol From randomisation (week 24) to end of treatment (week 40) ratio to baseline
Part 2: Change in body weight From randomisation (week 24) to end of treatment (week 40) kg
Part 2: Change in waist circumference From randomisation (week 24) to end of treatment (week 40) cm
Part 2: Relative change in VLDL cholesterol From randomisation (week 24) to end of treatment (week 40) ratio to baseline
Part 2: Change in HbA1c From randomisation (week 24) to end of treatment (week 40) Percentage point
Part 2: Change in fasting plasma glucose From randomisation (week 24) to end of treatment (week 40) mmol/l
Part 2: Number of emergent adverse events (TEAEs) From baseline at (week 0) to end of trial (week 48) Count of events
Part 2: Relative change in total cholesterol From randomisation (week 24) to end of treatment (week 40) ratio to baseline
Part 2: Relative change in LDL cholesterol From randomisation (week 24) to end of treatment (week 40) ratio to baseline
Part 2: Relative change in Triglycerides From randomisation (week 24) to end of treatment (week 40) ratio to baseline
Part 2: Number of serious treatment emergent adverse events (SAEs) From baseline at (week 0) to end of trial (week 48) Count of events
Trial Locations
- Locations (14)
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Jacksonville Ctr For Clin Res
🇺🇸Jacksonville, Florida, United States
Endo Res Solutions Inc
🇺🇸Roswell, Georgia, United States
East West Med Res Inst
🇺🇸Honolulu, Hawaii, United States
Evanston Premier Hlthcr Res
🇺🇸Skokie, Illinois, United States
Altasciences Clinical Kansas, Inc.
🇺🇸Overland Park, Kansas, United States
L-MARC Research Center
🇺🇸Louisville, Kentucky, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
Medical Uni of SC Charleston
🇺🇸Charleston, South Carolina, United States
Coastal Carolina Res Ctr.
🇺🇸North Charleston, South Carolina, United States
Soltero Cardiovascular Research Center
🇺🇸Dallas, Texas, United States
Chrysalis Clinical Research
🇺🇸Saint George, Utah, United States
Health Res of Hampton Roads
🇺🇸Newport News, Virginia, United States
National Clin Res Inc.
🇺🇸Richmond, Virginia, United States