New obesity drug aims to boost metabolism and burn fat faster
NCT ID NCT06745284
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
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18 to 65 years
- Sex
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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 Hide 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
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AdventHealth - Translation Research Institute
Orlando, Florida, 32804, United States
-
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808, United States
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