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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
NCT06309992 · View on ClinicalTrials.gov ↗
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06309992
The ClinicalTrials.gov registry entry for NCT06309992 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 218 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 203 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06309992 reports 20 study locations spanning 5 distinct geographic areas — top geographies include Florida, California, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06309992?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), Survodutide (COMBINATION_PRODUCT). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06309992?
This trial is sponsored by Boehringer Ingelheim, which has 203 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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