ObesityPhase 1NCT06745284
A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity
A Phase 1 study testing Survodutide and Semaglutide in people with Obesity, run by Boehringer Ingelheim at 2 sites in United States.
Trial summary
This study is open to adults between 18 and 65 years of age who have obesity. People can join the study if they have a body mass index (BMI) between 30 and 45 km/m². The purpose of this study is to find out whether a medicine called survodutide improves how the body uses energy and breaks down fat. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- Survodutide and Semaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 2 sitesUnited States
- Study dates
- 26 Mar 2025to 10 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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))
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Pennington Biomedical Research Center
Baton Rouge, Louisiana, 70808
AdventHealth - Translation Research Institute
Orlando, Florida, 32804
About this study
Official title: 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 open to adults between 18 and 65 years of age who have obesity. People can join the study if they have a body mass index (BMI) between 30 and 45 km/m². The purpose of this study is to find out whether a medicine called survodutide improves how the body uses energy and breaks down fat. This study compares survodutide with another medicine called semaglutide. Survodutide is being developed to treat people with obesity.
Semaglutide is already used to treat people with obesity.
Read more
Participants are put into 2 groups by chance. One group gets survodutide and the other group gets semaglutide. Participants get survodutide or semaglutide as an injection under the skin once a week. Participants are in the study for 8-10 months depending on how long the treatment is given. During this time, they visit the study site weekly. Some of the visits may also be done at the participant's home instead of the study site.
At some of the visits, doctors test how much energy a participant's body uses. This is done in a special room where they measure the oxygen that is breathed in and the carbon dioxide that is breathed out by the participant. The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
- Conditions
- Obesity
- Being tested
- Survodutide, Semaglutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurvodutideDrug
Also called BI 456906
Survodutide
SemaglutideDrug
Also called Wegovy®
Semaglutide
| Study group | Role | What they receive |
|---|---|---|
| Survodutide arm | Experimental | Not described Receives: Drug: Survodutide |
| Semaglutide arm | Active comparator | Not described Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute change in sleeping metabolic rate (SMR) (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Measured: at baseline, up to 36 weeks
Secondary outcomes (3)
Relative change in SMR (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Measured: at baseline, up to 36 weeks
Absolute change in fatty acid oxidation during sleep (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Measured: at baseline, up to 36 weeks
Relative change in fatty acid oxidation during sleep (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Measured: at baseline, up to 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start26 Mar 2025
- Primary completion8 Jan 2027 (estimated)
- Study completion10 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745284
- Sponsor's protocol ID
- 1404-0045
- Other IDs
- U1111-1309-3679
- Status last verified
- May 2026
- First submitted
- 19 Dec 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06745284
- Acronym / sponsor ID
- 1404-0045
- Conditions
- Obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 10 Jan 2027 (estimated)
- First posted
- 20 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is open to adults between 18 and 65 years of age who have obesity. People can join the study if they have a body mass index (BMI) between 30 and 45 km/m². The purpose of this study is to find out whether a medicine called survodutide improves how the body uses energy and breaks down fat. This study compares survodutide with another medicine called semaglutide. Survodutide is being developed to treat people with obesity.
Semaglutide is already used to treat people with obesity.
Participants are put into 2 groups by chance. One group gets survodutide and the other group gets semaglutide. Participants get survodutide or semaglutide as an injection under the skin once a week. Participants are in the study for 8-10 months depending on how long the treatment is given. During this time, they visit the study site weekly. Some of the visits may also be done at the participant's home instead of the study site.
At some of the visits, doctors test how much energy a participant's body uses. This is done in a special room where they measure the oxygen that is breathed in and the carbon dioxide that is breathed out by the participant. The results are compared between the 2 groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survodutide arm | Experimental | Drug: Survodutide |
| Semaglutide arm | Active comparator | Drug: Semaglutide |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurvodutideAlso: BI 456906Survodutide | Drug | Survodutide arm |
| SemaglutideAlso: Wegovy®Semaglutide | Drug | Semaglutide arm |
Primary outcome
Absolute change in sleeping metabolic rate (SMR) (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Time frame: at baseline, up to 36 weeks
3 secondary outcomes
Relative change in SMR (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Time frame: at baseline, up to 36 weeks
Absolute change in fatty acid oxidation during sleep (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Time frame: at baseline, up to 36 weeks
Relative change in fatty acid oxidation during sleep (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss
Time frame: at baseline, up to 36 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Survodutide and Semaglutide in people with Obesity, run by Boehringer Ingelheim at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute change in sleeping metabolic rate (SMR) (measured in a whole room calorimeter) from baseline to first visit a participant reached at least 10% weight loss (time frame: at baseline, up to 36 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.