NCT06214741

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 307 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 compared between the survodutide groups and placebo group to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Obesity
• Overweight

Interventions

Type	Name	Description
DRUG	survodutide	once weekly subcutaneous injection
DRUG	Placebo matching BI 456906	Once weekly subcutaneous injection

Timeline

• Start date: 2024-02-06
• Primary completion: 2025-07-29
• Completion: 2026-01-28
• First posted: 2024-01-22
• Last updated: 2026-02-04

Locations

28 sites across 1 country: China

Regulatory

• FDA-regulated drug study