SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

Part of paid clinical trials in Riverview, Florida.

Sponsor
Boehringer Ingelheim
Study ID
NCT07855900
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Oct 2, 2026
Start date
Nov 7, 2026
Status verified
Sep 2026
Primary completion
Jun 25, 2028
Completion
Jun 25, 2028

Study Design

Enrollment
350 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: SWITCH cohort
    Participants switching to survodutide
  • Experimental: INITIATION cohort
    Naive participants

Primary Outcome Measure

Percent change in body weight from baseline to Week 52 [ Time Frame: At baseline and Week 52 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Covenant Metabolic Specialist, LLC - RiverviewRiverviewFlorida33578
Boehringer Ingelheim
[email protected]
833-602-2368

Find similar trials in Riverview, FL

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By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Covenant Metabolic Specialist, LLC - Riverview· Riverview, FL

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