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Not yet recruitingPhase 3

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 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Injections, Phone or video check-ins, Questionnaires, Urine samples

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants take the medicine as an injection under the skin once a week."
  • "Participants are in the study for about 1 year and 2 months."
  • "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."
  • "They also check waist size, blood pressure, and take blood and urine samples."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether survodutide helps adults with overweight or obesity who do not have diabetes lose weight. Everyone gets the medicine as a shot under the skin once a week. The study lasts about 1 year and 2 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old and meet your country's legal age to consent.
  • Have a BMI of 30 or higher, or 27 or higher with at least one weight-related health problem. BMI is a measure based on height and weight.
  • Have tried to lose weight through dieting at least once without success.
  • Be able to decide for yourself to join and sign a consent form before joining.
  • If you can become pregnant, be willing and able to use highly effective birth control as required by the study.
  • Other rules for joining also apply.

Who can't join

  • Your weight changed by more than 2.5% during the lead-in period before screening.
  • Your obesity is caused by certain hormone problems or genetic conditions.
  • Your HbA1c is 6.5% or higher at screening. This blood test measures your average blood sugar.
  • You have a history of type 1 or type 2 diabetes.
  • You started medicine to lower blood sugar for diabetes within 3 months before screening or between screening and the starting visit.
  • Other rules that may keep you from joining also apply.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion criteria: 1. 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 2. History of at least one self-reported unsuccessful dietary effort to lose body weight 3. 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 4. 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. Exclusion criteria: 1. Body weight change (self-reported) \>2.5% during run-in period before screening 2. 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) 3. Hemoglobin A1c (HbA1c) ≥6.5% (≥48 mmol/mol) as measured by the central laboratory at screening 4. 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.

Study sites (1)

FL