A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight

Sponsor
Boehringer Ingelheim
Study ID
NCT06214741
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • survodutide — DRUG
    once weekly subcutaneous injection
  • Placebo matching BI 456906 — DRUG
    Once weekly subcutaneous injection

Study Details

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.

Key Dates

Start date
Feb 6, 2024
Status verified
Apr 2026
Primary completion
Jul 29, 2025
Completion
Jan 28, 2026

Study Design

Enrollment
307 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: survodutide 3.6 mg
  • Experimental: survodutide 4.8 mg
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage change in body weight from baseline to Week 52 [ Time Frame: At baseline and at Week 52. ]

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