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NCT06309992 · ClinicalTrials.gov registry record · Phase 3
A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight
A Phase 3 study of Obesity and Non-alcoholic Steatohepatitis (NASH), sponsored by Boehringer Ingelheim.
- Completed
- Registry status
- Phase 3
- Development phase
- 218
- Enrollment target
- 20
- Study locations
NCT06309992: Completed Phase 3 study of Obesity and Non-alcoholic Steatohepatitis (NASH), sponsored by Boehringer Ingelheim.
NCT06309992 is a Phase 3 study of Obesity and Non-alcoholic Steatohepatitis (NASH) that has completed, run by Boehringer Ingelheim. The registered enrollment target is 218 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06309992, a Phase 3 study of Obesity and Non-alcoholic Steatohepatitis (NASH), has completed, sponsored by Boehringer Ingelheim.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 218 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is open to adults who are at least 18 years old and have * presumed or confirmed NASH together with overweight or obesity and * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² and at least one weight-related health problem. People with a history of other chronic liver diseases cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people living with obesity or overweight and a confirmed or presumed liver disease called nonalcoholic steatohepatitis (NASH) to have less liver fat and to lose weight. Participants are put into 2 groups randomly, which means by chance. 1 group gets different doses of survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Every participant has a 2 in 3 chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week for about 1 year. In addition to the study medicine, all participants receive counselling to make changes to their diet and to exercise regularly. Participants are in the study for about 1 year and 3 months. During this time, it is planned that participants visit the study site up to 14 times and receive 3 phone calls by the site staff. The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At 3 of the visits, the participants' liver is measured using different imaging methods. The results are compared between the groups to see whether the treatment works.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT Survodutide
Study Locations (20)
Florida
- Excel Medical Clinical Trials - Boca Raton
- Segal Drug Trials - Delray Beach
- Fleming Island Center for Clinical Research - Fleming Island
- Covenant Metabolic Specialists, LLC - Fort Myers - Fort Myers
- Velocity Clinical Research-Hallandale Beach-67888 - Hallandale
- Nature Coast Clinical Research-Inverness-48221 - Inverness
- Health Awareness, Inc. - Jupiter
- Verus Clinical Research Corporation - Miami
- Panax Clinical Research - Miami Lakes
- Covenant Research and Clinics, LLC - Sarasota
California
- ARK Clinical Research - Fountain Valley
- Velocity Clinical Research-Gardena-69773 - Gardena
- ARK Clinical Research - Long Beach
- Catalina Research Institute, LLC - Montclair
- Velocity Clinical Research-North Hollywood-69852 - North Hollywood
- Velocity Clinical Research-Panorama City-68861 - Panorama City
- Velocity Clinical Research, Santa Ana - Santa Ana
Illinois
- Springfield Clinic, LLP - Springfield
Indiana
- Indiana University - Indianapolis
Iowa
- University of Iowa Hospitals and Clinics - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 218 participants |
| Start Date | 2024-04-02 |
| Est. Completion | 2025-12-02 |
| Phase | Phase 3 |
What the finished NCT06309992 record still lists
NCT06309992 is an interventional study that assigns participants to a tested intervention. The registered 218 participants enrollment target is mid-sized for trials with a published cap, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (73% lower).
The record links to 2 conditions, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06309992 names 20 study sites across 5 states, led by Florida, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT06309992 about?
NCT06309992 is a clinical study titled "A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight". This study is open to adults who are at least 18 years old and have * presumed or confirmed NASH together with overweight or obesity and * a body mass index (BMI) of 30 kg/m² or more, or * a BMI of 27 kg/m² and at least one weight-related health problem. People with a history of other chronic live...
What is the current status of trial NCT06309992?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 218 participants. The study started on 2024-04-02. Estimated completion is 2025-12-02.
What conditions does trial NCT06309992 study?
This clinical trial studies the following conditions: Obesity, Non-alcoholic Steatohepatitis (NASH).
What interventions are being tested in trial NCT06309992?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), Survodutide (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06309992?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06309992 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Indiana, Iowa. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06309992's enrollment target sits among peer trials
218 297th of 1053 higher than 757 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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