Phase Ib Trial to Assess Safety and Tolerability of Multiple Subcutaneous Doses of BI 3006337 in Patients With Overweight or Obesity and Hepatic Steatosis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 12
- 主要终点
- Number of Subjects With Drug-related Adverse Events (AEs)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 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
排除标准
- •- 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.
研究组 & 干预措施
BI 3006337 50 mg
Subject with overweight/obesity and steatosis received subcutaneous solution for administration of 50 milligram of BI 3006337 once weekly.
干预措施: BI 3006337 (Drug)
BI 3006337 100 mg
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 100 milligram of BI 3006337 once weekly.
干预措施: BI 3006337 (Drug)
BI 3006337 150 mg
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of 150 milligram of BI 3006337 once weekly.
干预措施: BI 3006337 (Drug)
Placebo
Subjects with overweight/obesity and steatosis received subcutaneous solution for administration of Placebo once weekly.
干预措施: Placebo matching BI 3006337 (Drug)
结局指标
主要结局
Number of Subjects With Drug-related Adverse Events (AEs)
时间窗: From drug administration of BI 3006337 until end of the treatment, up to 99 days
Number of subjects with drug-related adverse events (AEs) occurring between first administration of trial medication (BI 3006337 or placebo) and end of study (EOS) is reported.
次要结局
- Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Cmax,ss) After the Last Dose in Week 12(0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 hours after drug administration in week 12)
- Area Under the Concentration-time Curve of BI 3006337 in Serum Over the Dosing Interval Tau at Steady State (AUCτ,ss) After the Last Dose in Week 12(0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 and 504 hours after drug administration in week 12)
- Time From Dosing to the Maximum Measured Concentration of BI 3006337 in Serum at Steady State (Tmax,ss) After the Last Dose in Week 12(0 hours (prior to drug administration) and 3, 7, 11, 15, 23, 27, 31, 35, 39, 47, 72, 168 hours after drug administration in week 12)
- Relative Percentage Change in Liver Steatosis From Baseline After 12 Weeks of Treatment(Baseline (-48 to -4): the last observed measurement prior to drug administration, Day 85)