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New obesity drug aims to boost metabolism and burn fat faster

NCT ID NCT06745284

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether survodutide, a new weekly injection, helps people with obesity burn more energy and fat compared to the existing drug semaglutide (Wegovy). 64 adults aged 18-65 with a BMI between 30 and 45 will be randomly assigned to one of the two drugs. Researchers will measure changes in metabolism and fat burning using a special room that tracks oxygen and carbon dioxide. The study lasts 8-10 months and is currently active but not recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Survodutide (also known as BI 456906) and semaglutide (also known as Wegovy)
What this could lead to
If it works, survodutide could offer a new option for weight loss that may be more effective at boosting metabolism and fat burning than current treatments.
What could go wrong
This is a small, early-phase study with only 64 participants, so results may not apply to everyone. The drug may cause side effects or fail to show a clear benefit over semaglutide.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

64 people

The number who actually took part.

Started

Mar 2025

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Age of 18 to 65 years (inclusive) * Male or female subjects with obesity (defined as a body mass index (BMI) of ≥30 and ≤45 kg/m²) * Woman of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria and instructions on the duration of use is provided in the participant information * Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * In the investigator's opinion, are well-motivated, capable, and willing to: * Learn how to self-inject the investigational medicinal product (IMP), as required for this protocol (persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the IMP) * Inject the IMP or accept injection from a designated person --- Follow trial procedures for the duration of the trial, including, but not limited to: follow lifestyle advice (for example, dietary restrictions and exercise, maintain a diary, complete required questionnaires, and handle the IMP as described in the instruction for use (IFU)) Exclusion criteria: * Current or history of significant alcohol consumption (defined as intake of \>210 g/week in men and \>140 g/week in women on average over a consecutive period of more than 3 months) or are unwilling to stop alcohol consumption 48 h before admission to the research facility and until discharge * History of chronic liver disease / cirrhosis * Body weight variation (self-reported) \>5% within 3 months before Visit 1 (screening) * Medications for obesity (including over-the-counter medications) within 3 months before Visit 1 (screening) * Glycated haemoglobin (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the local laboratory at screening * History of type 1 diabetes mellitus (T1DM) or T2DM or treatment with glucose lowering agent started within 3 months before Visit 1 (screening) Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AdventHealth - Translation Research Institute

    Orlando, Florida, 32804, United States

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808, United States

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