NCT03856047

Research Study Investigating How Well NNC0174-0833 Works in People Suffering From Overweight or Obesity.

Investigation of Safety and Efficacy of NNC0174-0833 for Weight Management - a Dose Finding Trial.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 706 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will look at the change in body weight in people taking NNC0174-0833, liraglutide and "dummy" medicine, from the start to the end of the study. As well as taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what participants can do to lose weight. Participants will either take NNC0174-0833, liraglutide or "dummy" medicine - which treatment participants get is decided by chance. Participants will need to take one injection once a week or once a day, depending on the treatment. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 8 months. Participants will have 12 clinic visits with the study doctor.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DRUG	NNC0174-0833	Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
DRUG	Placebo (NNC0174-0833)	Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
DRUG	Liraglutide 3.0 mg	Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.
DRUG	Placebo (Liraglutide 3.0 mg)	Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-03-02
• Completion: 2021-03-25
• First posted: 2019-02-27
• Last updated: 2024-07-05
• Results posted: 2023-07-18

Locations

54 sites across 10 countries: United States, Canada, Denmark, Finland, Ireland, Japan, Poland, Serbia, South Africa, United Kingdom

Regulatory

• FDA-regulated drug study