A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• survodutide — COMBINATION_PRODUCT
  once weekly subcutaneous injection
• Placebo — COMBINATION_PRODUCT
  once weekly subcutaneous injection

Study Details

This study is open to adults who are at least 18 years old and have * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² or more and at least one health problem related to their weight. People with type 2 diabetes cannot take part in this study. Only people who have previously not managed to lose weight by changing their diet can participate. The purpose of this study is to find out whether a medicine called survodutide (BI 456906) helps people living with overweight or obesity to lose weight. Participants are divided into 3 groups by chance, like drawing names from a hat. 2 groups get different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants inject survodutide or placebo under their skin once a week for about one and a half years. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 7 months. During this time, it is planned that participants visit the study site up to 14 times and receive 6 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. The results are compared between the groups to see whether the treatment works.

Key Dates

Start date

Nov 25, 2023

Status verified

Mar 2026

Primary completion

Dec 2, 2025

Completion

Feb 20, 2026

Study Design

Enrollment

726 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Survodutide 3.6 mg
• Experimental: Survodutide 6.0 mg
• Placebo Comparator: Placebo

Primary Outcome Measure

Percentage change in body weight from baseline to Week 76 [ Time Frame: Baseline and at Week 76 ]

Locations (32)

Related coverage on Hipa.ai

• Survodutide Phase 3 Trial for Obesity Completes Primary Data Collection
  Survodutide · Dec 2, 2025 · ClinicalTrials.gov

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