ObesityPhase 3NCT07855900
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
A Phase 3 study testing Survodutide in people with Obesity, run by Boehringer Ingelheim at 2 sites in United States.
Trial summary
This study is open to adults with overweight or obesity. People can join the study if they have a body mass index (BMI) of 30 kg/m² or more, or a BMI of 27 kg/m² or more with at least one weight- related health problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Survodutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Nov 2026to 6 Nov 2029
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control as provided in the protocol Further inclusion criteria apply.
Who cannot join
- Body weight change (self-reported) >2.5% during run-in period before screening
- Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)
- Hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening
- History of Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) or treatment with glucose-lowering agent (for the purpose of treating diabetes) started within 3 months before the screening visit up to and including the baseline visit Further exclusion criteria apply.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
The Jones Center Clinical Research, LLC
Macon, Georgia, 31210
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Covenant Metabolic Specialist, LLC - Riverview
Riverview, Florida, 33578
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
About this study
Official title: A Phase IIIb, Open-label, Pragmatic Study Evaluating Initiation Strategies for Survodutide, Including de Novo Use and Switching From Semaglutide or Tirzepatide, in Participants With Overweight/Obesity Without Diabetes Mellitus-SYNCHRONIZE® - START
This study is open to adults with overweight or obesity. People can join the study if they have a body mass index (BMI) of 30 kg/m² or more, or a BMI of 27 kg/m² or more with at least one weight- related health problem. Participants must not have diabetes, and they must have tried to lose weight by dieting at least once in the past without success. The purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity lose weight.
This study has 2 groups. The groups differ based on their starting dose and whether they have used similar weight-loss medicines before. Participants are put into one of the 2 groups, but everyone in the study receives the study medicine, survodutide. Participants take the medicine as an injection under the skin once a week. The dose of the medicine is slowly increased over time and then kept at a steady level. If a participant has side effects, such as stomach problems, the study doctor can adjust their dose.
Participants are in the study for about 1 year and 2 months. During this time, they visit the study site about 12 times. The study staff will also contact the participants by phone or video call for extra check-ins. The participants fill in questionnaires about their physical abilities, social activities, and how their weight affects their daily and emotional life. During the study, doctors regularly measure body weight to see whether the treatment works. They also check waist size, blood pressure, and take blood and urine samples. The doctors also regularly check participants' health and take note of any unwanted effects.
- Conditions
- Obesity
- Being tested
- Survodutide
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurvodutideCombination product
Also called BI 456906
Survodutide
| Study group | Role | What they receive |
|---|---|---|
| SWITCH cohort | Experimental | Participants switching to survodutide Receives: Combination Product: Survodutide |
| INITIATION cohort | Experimental | Naive participants Receives: Combination Product: Survodutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in body weight from baseline to Week 52
Measured: At baseline and Week 52
Secondary outcomes (13)
Absolute change from baseline in PROMIS Physical Function (PF-SF10a) score (units on a scale) to Week 52
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function (PF) measure assesses self-reported capability in performing a range of physical activities. It evaluates perceived functioning of the upper extremities, lower extremities (mobility), and central body regions (neck, back), as well as activities of daily living. The 24-item PROMIS PF yields a total score reflecting physical function.
Measured: At baseline and Week 52
Absolute change from baseline in PROMIS Ability to Participate in Social Roles and Activities SF8a total score (units on a scale) to Week 52
The PROMIS Ability to Participate in Social Roles and Activities measure assesses perceived ability to perform usual social, family, leisure, and work roles. Items address limitations in engaging in routine activities, and responses are reverse-scored so that higher scores reflect better ability and fewer limitations.
The 35-item measure generates a single Ability-to-Participate score.
Measured: At baseline and Week 52
Absolute change from baseline in IWQOL-Lite-CT total scale score (units on a scale) to Week 52
The Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite CT) consists of 20 items, assessing 3 domains of obesity related quality of life: physical, physical function, and psychosocial. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
Measured: At baseline and Week 52
Absolute change from baseline in IWQOL-Lite-CT physical scale score (units on a scale) to Week 52
The Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite CT) consists of 20 items, assessing 3 domains of obesity related quality of life: physical, physical function, and psychosocial. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
Measured: At baseline and Week 52
Absolute change from baseline in IWQOL-Lite-CT physical function scale score (units on a scale) to Week 52
The Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite CT) consists of 20 items, assessing 3 domains of obesity related quality of life: physical, physical function, and psychosocial. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
Measured: At baseline and Week 52
Absolute change from baseline in IWQOL-Lite-CT psychosocial scale score (units on a scale) to Week 52
The Impact of Weight on Quality of Life-Lite Clinical Trial (IWQOL-Lite CT) consists of 20 items, assessing 3 domains of obesity related quality of life: physical, physical function, and psychosocial. Individual composite scale scores and a total score can be computed and are presented on a scale of 0 to 100, with higher scores indicating better function.
Measured: At baseline and Week 52
Absolute change from baseline to Week 52 in Body Mass Index (BMI) [kg/m2]
Measured: At baseline and Week 52
Absolute change from baseline to Week 52 in Waist circumference [cm]
Measured: At baseline and Week 52
Absolute change from baseline to Week 52 in Systolic Blood Pressure (SBP) [mmHg]
Three measurements will be captured at each scheduled assessment time point. The mean of these 3 measurements [or the mean of the available measurements if fewer] will be calculated and used in the endpoint definition.
Measured: At baseline and Week 52
Absolute change from baseline to Week 52 in Glycosylated Haemoglobin A1c (HbA1c) [%]
Measured: At baseline and Week 52
Relative change from baseline to Week 52 in High Sensitivity C-Reactive Protein (hs-CRP) [mg/L]
Measured: At baseline and Week 52
Relative change from baseline to Week 52 in Non-High-Density Lipoprotein (HDL) cholesterol [mg/dL]
Measured: At baseline and Week 52
Relative change from baseline to Week 52 in Triglycerides [mg/dL]
Measured: At baseline and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start7 Nov 2026 (estimated)
- Primary completion6 Nov 2029 (estimated)
- Study completion6 Nov 2029 (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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07855900
- Sponsor's protocol ID
- 1404-0127
- Other IDs
- U1111-1339-5379, 2026-527093-36-00
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Open-label, Pragmatic Study Evaluating Initiation Strategies for Survodutide, Including de Novo Use and Switching From Semaglutide or Tirzepatide, in Participants With Overweight/Obesity Without Diabetes Mellitus-SYNCHRONIZE® - START
- ClinicalTrials.gov ID
- NCT07855900
- Acronym / sponsor ID
- 1404-0127
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2026 (estimated)
- Primary completion
- 6 Nov 2029 (estimated)
- Study completion
- 6 Nov 2029 (estimated)
- First posted
- 2 Oct 2026 (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 with overweight or obesity. People can join the study if they have a body mass index (BMI) of 30 kg/m² or more, or a BMI of 27 kg/m² or more with at least one weight- related health problem. Participants must not have diabetes, and they must have tried to lose weight by dieting at least once in the past without success. The purpose of this study is to find out whether a medicine called survodutide helps people with overweight or obesity lose weight.
This study has 2 groups. The groups differ based on their starting dose and whether they have used similar weight-loss medicines before. Participants are put into one of the 2 groups, but everyone in the study receives the study medicine, survodutide. Participants take the medicine as an injection under the skin once a week. The dose of the medicine is slowly increased over time and then kept at a steady level. If a participant has side effects, such as stomach problems, the study doctor can adjust their dose.
Participants are in the study for about 1 year and 2 months. During this time, they visit the study site about 12 times. The study staff will also contact the participants by phone or video call for extra check-ins. The participants fill in questionnaires about their physical abilities, social activities, and how their weight affects their daily and emotional life. During the study, doctors regularly measure body weight to see whether the treatment works. They also check waist size, blood pressure, and take blood and urine samples. The doctors also regularly check participants' health and take note of any unwanted effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SWITCH cohort | Experimental | Combination Product: SurvodutideParticipants switching to survodutide |
| INITIATION cohort | Experimental | Combination Product: SurvodutideNaive participants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female, age ≥18 years at the time of signing informed consent, and at least the legal age of consent in countries where it is >18 years
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Signed and dated written informed consent in accordance with International Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. Persons must be capable of giving informed consent independently
- Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control as provided in the protocol Further inclusion criteria apply.
Key exclusion criteria (4 listed)
- Body weight change (self-reported) >2.5% during run-in period before screening
- Have obesity induced by other endocrinologic disorders (i.e. Cushing Syndrome) or diagnosed monogenetic or syndromic forms of obesity (i.e. melanocortin 4 receptor deficiency, leptin deficiency, or Prader Willi Syndrome)
- Hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening
- History of Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) or treatment with glucose-lowering agent (for the purpose of treating diabetes) started within 3 months before the screening visit up to and including the baseline visit Further exclusion criteria apply.
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 | Combination product | INITIATION cohort, SWITCH cohort |
Primary outcome
Percent change in body weight from baseline to Week 52
Time frame: At baseline and Week 52
13 secondary outcomes
Absolute change from baseline in PROMIS Physical Function (PF-SF10a) score (units on a scale) to Week 52
Time frame: At baseline and Week 52
Absolute change from baseline in PROMIS Ability to Participate in Social Roles and Activities SF8a total score (units on a scale) to Week 52
Time frame: At baseline and Week 52
Absolute change from baseline in IWQOL-Lite-CT total scale score (units on a scale) to Week 52
Time frame: At baseline and Week 52
Absolute change from baseline in IWQOL-Lite-CT physical scale score (units on a scale) to Week 52
Time frame: At baseline and Week 52
Absolute change from baseline in IWQOL-Lite-CT physical function scale score (units on a scale) to Week 52
Time frame: At baseline and Week 52
Absolute change from baseline in IWQOL-Lite-CT psychosocial scale score (units on a scale) to Week 52
Time frame: At baseline and Week 52
Absolute change from baseline to Week 52 in Body Mass Index (BMI) [kg/m2]
Time frame: At baseline and Week 52
Absolute change from baseline to Week 52 in Waist circumference [cm]
Time frame: At baseline and Week 52
Absolute change from baseline to Week 52 in Systolic Blood Pressure (SBP) [mmHg]
Time frame: At baseline and Week 52
Absolute change from baseline to Week 52 in Glycosylated Haemoglobin A1c (HbA1c) [%]
Time frame: At baseline and Week 52
Relative change from baseline to Week 52 in High Sensitivity C-Reactive Protein (hs-CRP) [mg/L]
Time frame: At baseline and Week 52
Relative change from baseline to Week 52 in Non-High-Density Lipoprotein (HDL) cholesterol [mg/dL]
Time frame: At baseline and Week 52
Relative change from baseline to Week 52 in Triglycerides [mg/dL]
Time frame: At baseline and Week 52
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 27 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Survodutide 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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 27 Oct 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in body weight from baseline to Week 52 (time frame: At baseline and Week 52). 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 27 Oct 2026.