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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05296733




Registration number
NCT05296733
Ethics application status
Date submitted
23/03/2022
Date registered
25/03/2022
Date last updated
9/01/2024

Titles & IDs
Public title
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
Scientific 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
Secondary ID [1] 0 0
2021-006247-10
Secondary ID [2] 0 0
1404-0010
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Liver Diseases 0 0
Obesity 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BI 456906

Experimental: Part A: BI 456906: Cohort 1 - Healthy subjects

Experimental: Part A: BI 456906: Cohort 2 - Patients with cirrhosis + Child-Turcotte-Pugh (CTP) Class A

Experimental: Part A: BI 456906: Cohort 3 - Patients with cirrhosis + CTP Class B

Experimental: Part A: BI 456906: Cohort 4 - Patients with cirrhosis + CTP Class C

Experimental: Part B: BI456906: Cohort 1 - Patients with overweight/obesity without cirrhosis/hepatic impairment

Experimental: Part B: BI456906: Cohort 2 - Patients with overweight/obesity with cirrhosis + CTP Class A

Experimental: Part B: BI456906: Cohort 3 - Patients with overweight/obesity with cirrhosis + CTP Class B


Treatment: Drugs: BI 456906
BI 456906
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-8)
Timepoint [1] 0 0
Up to 360 hours
Primary outcome [2] 0 0
Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)
Timepoint [2] 0 0
Up to 360 hours
Primary outcome [3] 0 0
Part B: Percentage of patients treated who experience treatment-emergent adverse event
Timepoint [3] 0 0
Up to Day 218
Secondary outcome [1] 0 0
Part A: Percentage of patients treated who experience treatment-emergent adverse event
Timepoint [1] 0 0
Up to Day 35

Eligibility
Key inclusion criteria
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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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 design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
27/04/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
29/12/2023
Sample size
Target
Accrual to date
Final
82
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas
Country [4] 0 0
Germany
State/province [4] 0 0
Bonn
Country [5] 0 0
Germany
State/province [5] 0 0
Hamburg
Country [6] 0 0
Germany
State/province [6] 0 0
Ulm
Country [7] 0 0
Hungary
State/province [7] 0 0
Budapest
Country [8] 0 0
Hungary
State/province [8] 0 0
Kistarcsa
Country [9] 0 0
New Zealand
State/province [9] 0 0
Auckland
Country [10] 0 0
Poland
State/province [10] 0 0
Wroclaw
Country [11] 0 0
Slovakia
State/province [11] 0 0
Bratislava

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05296733
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries