DRUG
BI 456906
BI 456906
Status
Completed
Phase
Phase 1
Enrollment
82
Locations
13
Results
Not posted
Publications
1
Study summary
This study is open to adults who have different levels of liver problems and adults who are healthy. People with or without overweight or obesity can take part. This study has 2 parts. The purpose of Part 1 is to find out whether having liver problems influences how BI 456906 is taken up in the body. The purpose of Part 2 is to find out whether having liver problems influences how people with overweight and obesity tolerate different doses of BI 456906. In Part 1, participants get a single injection of BI 456906 under their skin and stay at the study site for 2 nights afterwards. They are in the study for about a month. During this time, they visit the study site about 8 more times. The doctors compare the amount of BI 456906 in the blood of healthy people and people with liver problems. In Part 2, participants get 1 or 2 injections of BI 456906 once a week under their skin for 28 weeks. At the beginning, they get lower doses of BI 456906. Over time, they get higher doses until they reach a certain dose of BI 456906. This dose is then maintained until the end of the treatment. Participants in Part 2 are in the study for about 7 months. During this time, they visit the study site about 16 times and get about 15 phone calls from the site staff. The doctors record the number of people with health problems that could have been caused by treatment with BI 456906. They compare the results between participants with liver problems and those without liver problems. In both parts, doctors also regularly check participants' health and take note of any unwanted effects.
Interventions
DRUG
BI 456906
Timeline
First posted
Mar 25, 2022
Study start
Apr 27, 2022
Primary completion
Dec 29, 2023
Study completion
Dec 29, 2023
Results posted
Not reported
Registry updated
Aug 15, 2024
Outcomes
Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Time frame · Up to 360 hours
Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)
Time frame · Up to 360 hours
Part B: Percentage of patients treated who experience treatment-emergent adverse event
Time frame · Up to Day 218
Part A: Percentage of patients treated who experience treatment-emergent adverse event
Time frame · Up to Day 35
Eligibility
Inclusion Criteria -Part A: * Male or female subjects with age ≥18 years (or the minimum country specific age of consent if \>18 years) and 75 years, inclusive at the screening visit. * Body mass index (BMI) of 18.5-40.0 kg/m2 (inclusive). * Signed and dated written informed consent in accordance with International Council on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial. * Women of childbearing potential must be willing and able to use two forms of effective contraception where at least one form is highly effective method of birth control per ICH M3 (R2) that results in a low failure rate (i.e. \<1% per year when used consistently and correctly). A list of contraception methods meeting these criteria is provided in the subject information. Please note that oral contraceptives are not allowed during the treatment period. A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Further inclusion criteria apply. -Part B: * Male or female subjects between the ages of ≥18 (or the minimum country specific age of consent if \>18 years) and 75 years, inclusive, at the screening visit. * Subjects with overweight or obesity, defined as BMI ≥27 kg/m2 at the screening visit. * A minimum absolute body weight of 70 kg for females and 80 kg for males at the screening visit. * Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial. Further inclusion criteria apply. Exclusion criteria -Part A: * Estimated Glomerular Filtration Rate (eGFR) \<60 mL/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula). * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at screening. * Calcitonin ≥20 pg/mL (5.84 pmol/L) at the screening visit. * History of chronic or acute pancreatitis or elevation of serum lipase/amylase \>2×ULN, or fasting serum triglyceride levels of \>500 mg/dL (\>5.65 mmol/L) at screening. Further exclusion criteria apply. -Part B: * Prior surgery of the gastrointestinal tract that could interfere with body weight (including minimally invasive/endoscopic bariatric devices, bariatric surgery including metabolic operation that involves resection and/or reconstruction of any portion of the gastrointestinal tract) except appendectomy and simple hernia repair before randomization. However, a subject previously treated with reversible weight loss devices such as gastric banding, or intragastric balloon and removed longer than 12 months before screening should not be excluded. * Glycosylated Hemoglobin, Type A1 (HbA1c) ≥11% at screening or diagnosed with type 1 diabetes mellitus. * Exposure to Glucagon-like-peptide 1 (GLP-1) receptor agonist-based therapies (within 3 months prior to screening or within 5 half-lives of the drug, whichever is longer). * Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2, manifest hypo- or hyperthyroidism at screening. Further exclusion criteria apply.
Study locations
Germany · Hungary · New Zealand · Poland · Slovakia · United States. Showing up to 24 locations stored in the fast local snapshot.
Arizona Liver Health
Chandler, Arizona, United States
Covenant Metabolic Specialists, LLC
Fort Myers, Florida, United States
Covenant Metabolic Specialists, LLC
Sarasota, Florida, United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
IMA Clinical Research San Antonio
San Antonio, Texas, United States
Universitätsklinikum Bonn AöR
Bonn, Germany
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany
Universitätsklinikum Ulm
Ulm, Germany
Semmelweis University
Budapest, Hungary
CRU Hungary Ltd.
Kistarcsa, Hungary
New Zealand Clinical Research (NZCR)
Auckland, New Zealand
Dr. Piotr Napora, Center of Clinical Research
Wroclaw, Poland
SUMMIT CLINICAL RESEARCH, s.r.o.
Bratislava, Slovakia
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