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 | Not Yet Recruiting Phase 3 FDA Drug

• 3 other identifiers: 1404-0126U1111-1338-26842026-527092-29-00
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• Percentage change in body weight from baseline to Week 52

  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

  At baseline and Week 52

• Absolute change in IWQOL-Lite CT physical scale score (units on a scale) from baseline to Week 52

  At baseline and Week 52

• Absolute change in IWQOL-Lite CT physical function scale score (units on a scale) from baseline to Week 52

  At baseline and Week 52

• Absolute change in IWQOL-Lite CT psychosocial scale score (units on a scale) from baseline to Week 52

  At baseline and Week 52

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

  At baseline and Week 52

Study Arms (2)

Survodutide arm

EXPERIMENTAL

Combination Product: Survodutide

Placebo arm

PLACEBO COMPARATOR

Combination Product: Placebo

Interventions

Survodutide COMBINATION_PRODUCT

Survodutide

Also known as: BI 456906

Survodutide arm

Placebo COMBINATION_PRODUCT

Placebo matching survodutide

Placebo arm

Eligibility Criteria

• Age: 45 Years - 65 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Covenant Metabolic Specialist, LLC - Riverview

Riverview, Florida, 33578, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Obesity

Interventions

BI 456906

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2026
• First Posted: September 30, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): July 26, 2028
• Study Completion (Estimated): July 26, 2028
• Last Updated: September 30, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

US (1)