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New weekly shot aims to tackle fatty liver and obesity

NCT ID NCT05970640

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial tested an experimental drug called BI 3006337 in 64 adults who are overweight or obese and have fatty liver disease. Participants received weekly injections of either the drug or a placebo for about 4 months. The main goal was to check safety and tolerability, not yet to see if the drug works.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BI 3006337 (an experimental drug given as a weekly injection)
What this could lead to
If it works, this could point toward a treatment for fatty liver disease in people with overweight or obesity.
What could go wrong
This is a very early Phase 1 trial focused on safety, not effectiveness. The drug may cause side effects or fail to show benefit in larger studies.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

64 people

The number who actually took part.

Started

Aug 2023

Finished

Nov 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Male or female trial participants ≥18 years and ≤75 years of age at time of consent. Women of child-bearing potential (WOCBP) must be willing and able to use 2 forms of effective contraception where at least 1 form is a highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1% per year when used consistently and correctly. Male trial participants must be willing and able to use condom if their partner is a WOCBP * Body mass index (BMI) ≥25 - \<40 kg/m\^2 * Liver fat fraction ≥8% as measured by Magnetic resonance imaging proton density fat fraction (MRI-PDFF) * 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 Exclusion Criteria: \- Current or past significant alcohol consumption (daily alcohol consumption in women should not exceed more than one standard drink per day and two drinks per day for men, whereby one standard drink is equivalent to 12 oz beer \[5% alcohol\]; 5 ounces of wine \[12% alcohol\], 1.5 ounces of 80 proof \[40% alcohol\]) or inability to reliably quantify alcohol consumption based on Investigator judgement within the last 5 years. The Alcohol Use Disorders Identification Test (AUDIT) shall be used a standardized screening tool for alcohol use disorder * Intake of medications historically associated with liver injury, hepatic steatosis, or steatohepatitis (e.g. oral or intravenous corticosteroids, methotrexate, valproic acid, tamoxifen, tetracycline, amiodarone) for more than 14 consecutive days within 12 weeks prior to the screening visit * Presence of any form of acute or chronic liver disease other than simple steatosis (e.g. viral hepatitis, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency). Chronic viral hepatitis parameters that would be considered exclusionary for the participation to this trial are (hepatitis B and C testing will be done at the screening visit): * Hepatitis B virus (HBV): trial participants with positive Hepatitis B virus surface antigen (HbsAg) * Hepatitis C virus (HCV): trial participants with positive HCV RNA. Trial participants treated for hepatitis C must have a negative RNA test at screening and also be HCV RNA negative for at least 3 years prior to screening in order to be eligible for the trial * Liver stiffness \>10 Kilopascal (kPa) as measured using Fibroscan. In patients with a non-valid Fibroscan measurement, a Fib-4 score \>1.3 should be considered exclusionary. * Suspicion, confirmed diagnosis, or history of hepatocellular carcinoma * Treatment with vitamin E (at a minimum dose of 800 IU/day) or pioglitazone not stable (in the opinion of the Investigator) within 90 days before screening * History of type 1 diabetes * Use of Glucagon-like peptide 1 (GLP1)-receptor agonists within last 90 days before screening Further exclusion criteria apply.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • AMR Knoxville

    Knoxville, Tennessee, 37920, United States

  • Accel Research Sites-Deland-67606

    DeLand, Florida, 32720, United States

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas, 78215, United States

  • Catalina Research Institute, LLC-Montclair-49051

    Montclair, California, 91763, United States

  • Centricity Research-Columbus-68879

    Columbus, Ohio, 43213, United States

  • Endeavor Clinical Trials

    San Antonio, Texas, 78240, United States

  • Floridian Clinical Research-Miami Lakes-68368

    Miami Lakes, Florida, 33016, United States

  • The Liver Institute at Methodist Dallas

    Dallas, Texas, 75203, United States

  • Velocity Clinical Research-Chula Vista

    Chula Vista, California, 91911, United States

  • Velocity Clinical Research-La Mesa-69117

    La Mesa, California, 91942, United States

  • Velocity Clinical Research-West Jordan-69043

    West Jordan, Utah, 84088, United States

  • iResearch Atlanta

    Decatur, Georgia, 30030, United States

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