Survodutide

Survodutide

Evidence & Status

  • Strong Human Evidence
  • Strong

At a Glance

An investigational GLP-1/glucagon receptor peptide with published Phase 3 obesity results. It is not FDA approved.

Plain English

Survodutide is being tested as a weight-loss medicine. A large trial found greater average weight loss than placebo, but stomach and bowel side effects were common and often led people to stop treatment.

Overview

Survodutide, also called BI 456906, is an investigational peptide that activates GLP-1 and glucagon receptors. Published randomized studies include a Phase 3 obesity trial of once-weekly subcutaneous treatment. Trial results do not constitute marketing approval.

Research Summary

In the 725-person, 76-week SYNCHRONIZE-1 trial in adults with obesity or overweight and a related complication, excluding diabetes, mean weight changes under the treatment-regimen analysis were -12.2% and -13.0% in the two survodutide groups versus -5.4% with placebo. Gastrointestinal events occurred in 80.9% and 89.7% versus 47.9%. Serious adverse events were reported in 8.3% of each treatment group versus 6.2% with placebo. Adverse events led to stopping assigned treatment in 23.7% and 24.8% versus 5.4%. Gallstones and gallbladder inflammation were also reported more often in treatment groups. These are trial observations; they do not establish that every reported event was caused by survodutide. Do not substitute results from the trial's different efficacy analysis.

Research Areas

  • Obesity
  • Weight management
  • GLP-1/glucagon receptor research

Safety & Risks

Serious Risks

  • Gallbladder events, including gallstones and gallbladder inflammation, were reported more often with survodutide than placebo in the 76-week trial; causality and longer-term risk are not established.

Reported Side Effects

  • Nausea
  • Vomiting
  • Diarrhea
  • Constipation
United States
Investigational; not FDA-approved.
United Kingdom
Current authorization status not established in this record.
Australia
Current authorization status not established in this record.
Canada
Current authorization status not established in this record.

Citations & Sources