CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 706 enrolled
Drug / intervention
NNC0174-0833 +3 moredrug
Likely dose
Liraglutide 3.0 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03856047
NCT03856047Phase 2Completed

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

Novo Nordisk A/S·interventional·Posted Feb 27, 2019·Updated Jul 5, 2024

In Brief

A Phase 2 clinical trial evaluating NNC0174-0833, Placebo (NNC0174-0833), and 2 other interventions for Overweight and Obesity. Completed, enrolled 706 participants across 54 sites in 10 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOverweight, Obesity
CountriesCanada, Denmark, Finland, Ireland, Japan, Poland, Serbia, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedFeb 27, 2019
Enrollment StartMar 1, 2019
Primary CompletionMar 2, 2020
Study CompletionMar 25, 2021
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 7.3 years ago

Interventions

NNC0174-0833drug

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.

Placebo (NNC0174-0833)drug

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.

Liraglutide 3.0 mgdrug

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.

Placebo (Liraglutide 3.0 mg)drug

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.