ObesityPhase 3NCT07850050
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
A Phase 3 study testing Survodutide in people with Obesity, run by Boehringer Ingelheim at 16 sites in 2 countries.
Trial summary
This study is open to women up to 65 years of age who are living with overweight or obesity and are going through or have finished menopause. People can join this study if they have a Body Mass Index (BMI) of 30 kg/m² or more, or if their BMI is 27 kg/m² or more and they have one or more weight related health… Read more about this study
- Who is it for?
- Ages 45 to 65 years, women only
- Conditions the study is for
- Obesity
- What is being tested?
- Survodutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 31 Oct 2026to 26 Jul 2028
- 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 45 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed and dated written informed consent in accordance with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Female (sex assigned at birth) with age >18 years at the time of screening
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Women of Childbearing Potential (WOCBP) must be ready and able to use at least an acceptable effective contraceptive method of birth control Further inclusion criteria apply.
Who cannot join
- Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM)
- Glycosylated Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening (Visit 1)
- Treatment with any medication for the indication of obesity within 90 days before screening
- Body weight change (self-reported) >5% within 90 days before screening (Visit 1) Further exclusion criteria apply.
Trial locations and contacts
16 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
16 sites in 2 countries
United States14 sites
Flourish Research
Birmingham, Alabama, 35205
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Flourish Research
Bowie, Maryland, 20715
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
The Center for Diabetes and Endocrine Care
Fort Lauderdale, Florida, 33312
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Jacksonville Center for Clinical Research
Jacksonville, Florida, 32216
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Flourish Research
Mandeville, Louisiana, 70471
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Flourish Research
Merritt Island, Florida, 32952
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Flourish Research
Metairie, Louisiana, 70006
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Lucas Research, Inc.
Morehead City, North Carolina, 28557
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Flourish Research
Northridge, California, 91325
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
West Orange Endocrinology, PA
Ocoee, Florida, 34761
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
McKay-Dee Hospital
Ogden, Utah, 84403
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Diabetes Associates Medical Group
Orange, California, 92868
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Covenant Metabolic Specialist, LLC - Riverview
Riverview, Florida, 33578
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
Flourish Research
Walnut Creek, California, 94598
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
United Kingdom2 sites
Glasgow Royal Infirmary
Glasgow, G4 0SF
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Leicester General Hospital
Leicester, LE5 4PW
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
About this study
Official title: A Multicentre, Randomised, Double-blind, Placebo-controlled 52-week, Phase IIIb Trial to Evaluate the Efficacy and Safety of Survodutide in Peri- and Post-menopausal Women With Overweight or Obesity (SYNCHRONIZE®-HERA)
This study is open to women up to 65 years of age who are living with overweight or obesity and are going through or have finished menopause. People can join this study if they have a Body Mass Index (BMI) of 30 kg/m² or more, or if their BMI is 27 kg/m² or more and they have one or more weight related health problems. Participants must also have tried to lose weight by dieting at least once in the past without success. People with pre-existing diabetes cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps women with overweight or obesity lose weight.
Participants are put into 2 groups randomly, which means by chance. Participants have a 1 in 2 chance of receiving survodutide. One group gets survodutide as an injection under the skin. The other group gets a placebo as an injection under the skin. The placebo looks like the study medicine but does not contain any medicine. Participants take the injections once a week. All participants also receive advice on diet and physical activity.
Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site about 12 times and get a few phone calls from the site staff. At the study visits, doctors regularly check participants' body weight. The results are compared between the 2 groups to see whether the treatment works. The participants fill in questionnaires about their menopause symptoms and how the symptoms affect their daily life. To assess the study endpoints, participants regularly have blood samples taken. The doctors also regularly check participants' health and take note of any unwanted effects.
- Conditions
- Obesity
- Being tested
- Survodutide, Placebo
- 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
PlaceboCombination product
Placebo matching survodutide
| Study group | Role | What they receive |
|---|---|---|
| Survodutide arm | Experimental | Not described Receives: Combination Product: Survodutide |
| Placebo arm | Placebo comparator | Not described Receives: Combination Product: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage change in body weight from baseline to Week 52
Measured: At baseline and Week 52
Secondary outcomes (20)
Key secondary endpoint: Absolute change in IWQOL-Lite CT total scale score (units on a scale) from baseline 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 in IWQOL-Lite CT physical scale score (units on a scale) from baseline 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 in IWQOL-Lite CT physical function scale score (units on a scale) from baseline 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 in IWQOL-Lite CT psychosocial scale score (units on a scale) from baseline 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 in patient-reported outcome 1 from baseline to Week 52
Measured: At baseline and Week 52
Absolute change in patient-reported outcome 2 frequency from baseline to Week 52
Measured: At baseline and Week 52
Absolute change in patient-reported outcome 2 severity from baseline to Week 52
Measured: At baseline and Week 52
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52
Measured: At baseline and Week 52
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52
Measured: At baseline and Week 52
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 52
Measured: At baseline and Week 52
Absolute change in PROMIS Physical Function score (PF-SF10a) (units on a scale) from baseline to Week 52
The Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities SF10a 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 in Body Mass Index (BMI) (kg/m2) from baseline to Week 52
Measured: At baseline and Week 52
Absolute in waist circumference (cm) from baseline to Week 52
Measured: At baseline and Week 52
Absolute change in systolic blood pressure (mmHg) from baseline to Week 52
Measured: At baseline and Week 52
Absolute change in Glycosylated Haemoglobin A1c (HbA1c) (%) from baseline to Week 52
Measured: At baseline and Week 52
Relative change in Low-Density Lipoprotein (LDL) cholesterol (%) from baseline to Week 52
Measured: At baseline and Week 52
Relative change in triglycerides (%) from baseline to Week 52
Measured: At baseline and Week 52
Relative change in High-Density Lipoprotein (HDL) (%) from baseline to Week 52
Measured: At baseline and Week 52
Relative change in non-HDL (%) from baseline to Week 52
Measured: At baseline and Week 52
Relative change in high sensitivity C-reactive protein (hsCRP) (%) from baseline to Week 52
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 posted30 Sep 2026
- Study start31 Oct 2026 (estimated)
- Primary completion26 Jul 2028 (estimated)
- Study completion26 Jul 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 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
- NCT07850050
- Sponsor's protocol ID
- 1404-0126
- Other IDs
- U1111-1338-2684, 2026-527092-29-00
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 30 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomised, Double-blind, Placebo-controlled 52-week, Phase IIIb Trial to Evaluate the Efficacy and Safety of Survodutide in Peri- and Post-menopausal Women With Overweight or Obesity (SYNCHRONIZE®-HERA)
- ClinicalTrials.gov ID
- NCT07850050
- Acronym / sponsor ID
- 1404-0126
- Conditions
- Obesity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 26 Jul 2028 (estimated)
- Study completion
- 26 Jul 2028 (estimated)
- First posted
- 30 Sep 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 women up to 65 years of age who are living with overweight or obesity and are going through or have finished menopause. People can join this study if they have a Body Mass Index (BMI) of 30 kg/m² or more, or if their BMI is 27 kg/m² or more and they have one or more weight related health problems. Participants must also have tried to lose weight by dieting at least once in the past without success. People with pre-existing diabetes cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps women with overweight or obesity lose weight.
Participants are put into 2 groups randomly, which means by chance. Participants have a 1 in 2 chance of receiving survodutide. One group gets survodutide as an injection under the skin. The other group gets a placebo as an injection under the skin. The placebo looks like the study medicine but does not contain any medicine. Participants take the injections once a week. All participants also receive advice on diet and physical activity.
Participants are in the study for up to 1 year and 2 months. During this time, they visit the study site about 12 times and get a few phone calls from the site staff. At the study visits, doctors regularly check participants' body weight. The results are compared between the 2 groups to see whether the treatment works. The participants fill in questionnaires about their menopause symptoms and how the symptoms affect their daily life. To assess the study endpoints, participants regularly have blood samples taken. 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
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Survodutide arm | Experimental | Combination Product: Survodutide |
| Placebo arm | Placebo comparator | Combination Product: Placebo |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Signed and dated written informed consent in accordance with International Conference of Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
- Female (sex assigned at birth) with age >18 years at the time of screening
- History of at least one self-reported unsuccessful dietary effort to lose body weight
- Women of Childbearing Potential (WOCBP) must be ready and able to use at least an acceptable effective contraceptive method of birth control Further inclusion criteria apply.
Key exclusion criteria (4 listed)
- Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM)
- Glycosylated Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening (Visit 1)
- Treatment with any medication for the indication of obesity within 90 days before screening
- Body weight change (self-reported) >5% within 90 days before screening (Visit 1) 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 | Survodutide arm |
| PlaceboPlacebo matching survodutide | Combination product | Placebo arm |
Primary outcome
Percentage change in body weight from baseline to Week 52
Time frame: At baseline and Week 52
20 secondary outcomes
Key secondary endpoint: Absolute change in IWQOL-Lite CT total scale score (units on a scale) from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in IWQOL-Lite CT physical scale score (units on a scale) from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in IWQOL-Lite CT physical function scale score (units on a scale) from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in IWQOL-Lite CT psychosocial scale score (units on a scale) from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in patient-reported outcome 1 from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in patient-reported outcome 2 frequency from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in patient-reported outcome 2 severity from baseline to Week 52
Time frame: At baseline and Week 52
Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52
Time frame: At baseline and Week 52
Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52
Time frame: At baseline and Week 52
Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in PROMIS Physical Function score (PF-SF10a) (units on a scale) from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in Body Mass Index (BMI) (kg/m2) from baseline to Week 52
Time frame: At baseline and Week 52
Absolute in waist circumference (cm) from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in systolic blood pressure (mmHg) from baseline to Week 52
Time frame: At baseline and Week 52
Absolute change in Glycosylated Haemoglobin A1c (HbA1c) (%) from baseline to Week 52
Time frame: At baseline and Week 52
Relative change in Low-Density Lipoprotein (LDL) cholesterol (%) from baseline to Week 52
Time frame: At baseline and Week 52
Relative change in triglycerides (%) from baseline to Week 52
Time frame: At baseline and Week 52
Relative change in High-Density Lipoprotein (HDL) (%) from baseline to Week 52
Time frame: At baseline and Week 52
Relative change in non-HDL (%) from baseline to Week 52
Time frame: At baseline and Week 52
Relative change in high sensitivity C-reactive protein (hsCRP) (%) from baseline to Week 52
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 30 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.
16 sites in 2 countries: 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 16 sites in 2 countries.
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 30 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 16 sites in United States, United Kingdom. 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. Some participants in this study may receive a placebo. 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?
Percentage 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 30 Oct 2026.