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Trial · Interventional

Not yet recruitingPhase 3Registry data

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

NCTNCT07850050 (opens ClinicalTrials.gov in a new tab)Other id1404-0126Other idU1111-1338-2684Other id2026-527092-29-00
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Not yet recruiting
Phase
Phase 3
Enrollment
600 participants (estimated)
Sponsor
Boehringer Ingelheim · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
31 Oct 2026 (estimated)
Primary completion
26 Jul 2028 (estimated)
Completion
26 Jul 2028 (estimated)
First posted
30 Sept 2026
Last update posted
30 Sept 2026
Conditions
Obesity

Timeline

1 trial · 1 not yet recruiting

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 3

    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

    NCT07850050

    est. 31 Oct 2026 to est. 26 Jul 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SurvodutideCombination product
  • PlaceboCombination product

Arms2

  • Experimental

    Survodutide arm

  • Placebo comparator

    Placebo arm

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Percentage change in body weight from baseline to Week 52

    Time frame · At baseline and Week 52

Secondary outcomes(20)

  1. 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

    Registry description

    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.

  2. 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

    Registry description

    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.

  3. 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

    Registry description

    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.

  4. 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

    Registry description

    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.

  5. Absolute change in patient-reported outcome 1 from baseline to Week 52

    Time frame · At baseline and Week 52

  6. Absolute change in patient-reported outcome 2 frequency from baseline to Week 52

    Time frame · At baseline and Week 52

  7. Absolute change in patient-reported outcome 2 severity from baseline to Week 52

    Time frame · At baseline and Week 52

  8. Achievement of body weight reduction ≥5% (yes/no) from baseline to Week 52

    Time frame · At baseline and Week 52

  9. Achievement of body weight reduction ≥10% (yes/no) from baseline to Week 52

    Time frame · At baseline and Week 52

  10. Achievement of body weight reduction ≥20% (yes/no) from baseline to Week 52

    Time frame · At baseline and Week 52

  11. 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

    Registry description

    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.

  12. Absolute change in Body Mass Index (BMI) (kg/m2) from baseline to Week 52

    Time frame · At baseline and Week 52

  13. Absolute in waist circumference (cm) from baseline to Week 52

    Time frame · At baseline and Week 52

  14. Absolute change in systolic blood pressure (mmHg) from baseline to Week 52

    Time frame · At baseline and Week 52

  15. Absolute change in Glycosylated Haemoglobin A1c (HbA1c) (%) from baseline to Week 52

    Time frame · At baseline and Week 52

  16. Relative change in Low-Density Lipoprotein (LDL) cholesterol (%) from baseline to Week 52

    Time frame · At baseline and Week 52

  17. Relative change in triglycerides (%) from baseline to Week 52

    Time frame · At baseline and Week 52

  18. Relative change in High-Density Lipoprotein (HDL) (%) from baseline to Week 52

    Time frame · At baseline and Week 52

  19. Relative change in non-HDL (%) from baseline to Week 52

    Time frame · At baseline and Week 52

  20. Relative change in high sensitivity C-reactive protein (hsCRP) (%) from baseline to Week 52

    Time frame · At baseline and Week 52

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 45 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion criteria: 1. 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 2. Female (sex assigned at birth) with age \>18 years at the time of screening 3. History of at least one self-reported unsuccessful dietary effort to lose body weight 4. 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. Exclusion criteria: 1. Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM) 2. Glycosylated Haemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening (Visit 1) 3. Treatment with any medication for the indication of obesity within 90 days before screening 4. Body weight change (self-reported) \>5% within 90 days before screening (Visit 1) Further exclusion criteria apply.

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