Phase 3Completed
A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight
A Phase III, Randomized, Double-blind, Parallel-group, Efficacy and Safety Study of BI 456906 Administered Subcutaneously Compared With Placebo in Chinese Participants With a BMI >=28 kg/m2 or BMI >=24 kg/m2 With at Least One Weight-related Complication
- Sponsor
- Boehringer Ingelheim (Industry)
- Enrollment
- 307 enrolled
- Conditions
- Obesity; Overweight
- Interventions
- survodutide; Placebo matching BI 456906
- Ages
- adults, older adults
- Registry
- NCT06214741
Full record on ClinicalTrials.gov
From the registry
This study in China is open to adults who are at least 18 years old who are living with overweight or obesity. People with a body mass index (BMI) of 28 kg/m\^2 or higher or 24 kg/m\^2 or higher with at least 1 weight related problem can join the study. The main purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity. 2 different doses of survodutide are tested in this study. Participants are put into 3 groups by chance. Each participant has an equal chance of being in each group. 2 groups get different doses of survodutide. 1 group gets placebo. Participants get survodutide or placebo as injections under the skin once a week for about 19 months. Placebo injections look like survodutide injections but do not contain any medicine. Participants are in the study for about 21 months. During this time, there are 20 visits. 14 visits are in person at the study site. Where possible, 6 visits can be done by video call, or by phone in rare cases. During this time, doctors regularly measure participant's body weight. Results are…
Primary outcomes
- Percentage change in body weight from baseline to Week 52
- Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52
History
Last registry update
Study completion
Primary completion
Started
Registered
Papers citing this trial
- Survodutide for Obesity in Chinese Adults: Phase 3 Randomized Trial Design and Baseline Characteristics (SYNCHRONIZE™-CN)
Diabetes therapy : research, treatment and education of diabetes and related disorders
In the news
TrialsMix Online (opens Mix Online in a new tab)
Boehringer Ingelheim reports significant weight loss with survodutide in Japanese obesity trial
The phase 3 SYNCHRONIZE-JP trial tested the dual glucagon/GLP-1 receptor agonist in Japanese patients with obesity.
TrialsNEJM (opens NEJM in a new tab)
NEJM reports on weekly survodutide for obesity and diabetes
The journal published findings evaluating weekly administration of survodutide in adult patients diagnosed with both excess weight and type 2 diabetes.
