Clinical trial NCT05970640: A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-alcoholic Fatty Liver Disease
Obesity
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2023-08-01
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Occurrence of drug-related adverse events (AEs)
timeFrame: Up to 99 days
Secondary outcomes:
measure: Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss) after the last dose in Week 12
timeFrame: Up to 99 days
measure: Maximum measured concentration of the analyte in serum at steady state (Cmax,ss) after the last dose in Week 12
timeFrame: Up to 99 days
measure: 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
timeFrame: Up to 99 days
measure: Relative percentage change in liver steatosis from baseline after 12 weeks of treatment
timeFrame: At baseline and at week 12
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Velocity Clinical Research-Chula Vista-67286
state: California
city: La Mesa
country: United States
facility: Velocity Clinical Research-La Mesa-69117
state: California
city: Montclair
country: United States
facility: Catalina Research Institute, LLC-Montclair-49051
state: California
city: DeLand
country: United States
facility: Accel Research Sites-Deland-67606
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research-Miami Lakes-68368
state: Florida
city: Decatur
country: United States
facility: iResearch Atlanta
state: Georgia
city: Columbus
country: United States
facility: Centricity Research-Columbus-68879
state: Ohio
city: Knoxville
country: United States
facility: AMR Knoxville
state: Tennessee
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation at the Texas Liver Institute
state: Texas
city: San Antonio
country: United States
facility: Endeavor Clinical Trials
state: Texas
city: West Jordan
country: United States
facility: Velocity Clinical Research-West Jordan-69043
state: Utah
Study officials:
References: