A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease

Obesity Clinical Trial

Official title:

Phase Ib Trial to Assess Safety and Tolerability of Multiple Subcutaneous Doses of BI 3006337 in Patients With Overweight or Obesity and Hepatic Steatosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05970640
• Other study ID #: 1466-0002
• Status: Recruiting
• Phase: Phase 1
• Start date: August 2, 2023
• Est. completion date: January 4, 2025

Study information

• Verified date: June 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is open to adults with overweight or obesity who also have fatty liver disease. The purpose of this study is to find the highest dose of BI 3006337 that people with overweight or obesity and with fatty liver disease can tolerate.

Participants are divided into 4 groups of equal size randomly, which means by chance. Different doses of BI 3006337 are given to participants in each group. Participants in each group receive an injection of either BI 3006337 or placebo once a week. Placebo injections look like BI 3006337 injections but do not contain any medicine.

Participants are in the study for about 4 months. During this time, they visit the study site 18 times. Three of the visits include overnight stays at the study site. The doctors check the health of the participants and note any health problems that could have been caused by BI 3006337.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 56
• Est. completion date: January 4, 2025
• Est. primary completion date: January 4, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Non-alcoholic Fatty Liver Disease
• Obesity
• Overweight

Intervention

Drug:
• BI 3006337
BI 3006337
• Placebo matching BI 3006337
Placebo matching BI 3006337

Locations

Country	Name	City	State
United States	Velocity Clinical Research	Chula Vista	California
United States	Centricity Research	Columbus	Ohio
United States	The Liver Institute at Methodist Dallas	Dallas	Texas
United States	iResearch Atlanta	Decatur	Georgia
United States	Accel Research Sites	DeLand	Florida
United States	Research Centers of America	Hollywood	Florida
United States	AMR Knoxville	Knoxville	Tennessee
United States	Velocity Clinical Research	La Mesa	California
United States	Clinical Pharmacology of Miami	Miami	Florida
United States	Floridian Clinical Research	Miami Lakes	Florida
United States	Catalina Research Institute, LLC	Montclair	California
United States	American Research Corporation at the Texas Liver Institute	San Antonio	Texas
United States	Endeavor Clinical Trials	San Antonio	Texas
United States	Velocity Clinical Research	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of drug-related adverse events (AEs)		Up to 99 days
Secondary	Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCt,ss) after the last dose in Week 12		Up to 99 days
Secondary	Maximum measured concentration of the analyte in serum at steady state (Cmax,ss) after the last dose in Week 12		Up to 99 days
Secondary	Time from dosing to the maximum measured concentration of the analyte in serum at steady state (tmax,ss) after the last dose in Week 12		Up to 99 days
Secondary	Relative percentage change in liver steatosis from baseline after 12 weeks of treatment	Liver steatosis is measured by Magnetic resonance imaging proton density fat fraction (MRI-PDFF)	At baseline and at week 12

External Links

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