A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906

Healthy Clinical Trial

Official title:

A Non-randomised, Open-label, 2-part, Parallel-cohort Trial to Evaluate 1) Pharmacokinetics, Safety, and Tolerability of a Single Subcutaneous Dose of BI 456906 in Patients With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Healthy Subjects With and Without Overweight/Obesity and 2) Safety and Tolerability of Multiple Subcutaneous Doses of BI 456906 in Patients With Overweight/Obesity With Cirrhosis and Varying Degrees of Hepatic Impairment Relative to Patients With Overweight/Obesity Without Cirrhosis/Hepatic Impairment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05296733
• Other study ID #: 1404-0010
• Secondary ID: 2021-006247-10
• Status: Completed
• Phase: Phase 1
• Start date: April 27, 2022
• Est. completion date: December 29, 2023

Study information

• Verified date: January 2024
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: December 29, 2023
• Est. primary completion date: December 29, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

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.

Related Conditions & MeSH terms

• Healthy
• Liver Diseases
• Obesity
• Overweight

Intervention

Drug:
• BI 456906
BI 456906

Locations

Country	Name	City	State
Germany	Universitätsklinikum Bonn AöR	Bonn
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Universitätsklinikum Ulm	Ulm
Hungary	Semmelweis University	Budapest
Hungary	CRU Hungary Ltd.	Kistarcsa
New Zealand	New Zealand Clinical Research (NZCR)	Auckland
Poland	Dr. Piotr Napora, Center of Clinical Research	Wroclaw
Slovakia	SUMMIT CLINICAL RESEARCH, s.r.o.	Bratislava
United States	Arizona Liver Health	Chandler	Arizona
United States	Covenant Metabolic Specialists, LLC	Fort Myers	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	Covenant Metabolic Specialists, LLC	Sarasota	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Germany,  Hungary,  New Zealand,  Poland,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)		Up to 360 hours
Primary	Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)		Up to 360 hours
Primary	Part B: Percentage of patients treated who experience treatment-emergent adverse event		Up to Day 218
Secondary	Part A: Percentage of patients treated who experience treatment-emergent adverse event		Up to Day 35

External Links

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