Testing Survodutide for Energy Use and Fat Breakdown in Obesity

An Active-comparator-controlled, Open-label, Parallel Group Study to Evaluate the Effect of Survodutide on Energy Expenditure and Fatty Acid Oxidation in Subjects With Obesity

This study is testing if a new medication called survodutide can help adults with obesity use energy better and break down fat more effectively compared to an existing treatment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 2 sites (Orlando, Florida and 1 other locations)
• Trial ID: NCT06745284 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of a medication called survodutide in improving energy utilization and fat breakdown in adults with obesity. Participants aged 18 to 65 with a BMI between 30 and 45 kg/m² will be randomly assigned to receive either survodutide or semaglutide, an existing obesity treatment, through weekly injections. The study lasts 8-10 months, with regular visits to the study site or home to monitor progress and energy metabolism. The goal is to determine if survodutide offers advantages over semaglutide in managing obesity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 with a BMI between 30 and 45 kg/m² who are motivated to manage their obesity.

Not a fit: Patients with a BMI outside the specified range or those who cannot self-inject the medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new option for improving energy metabolism and fat loss in individuals with obesity.

How similar studies have performed: Other studies have shown success with similar medications for obesity, indicating potential for this approach.

Eligibility criteria

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.

Where this trial is running

Orlando, Florida and 1 other locations

• Translational Research Institute for Metabolism and Diabetes — Orlando, Florida, United States (Recruiting)
• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Obesity