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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05296733
Ethics application status
Date submitted
23/03/2022
Date registered
25/03/2022
Date last updated
15/08/2024

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
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

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)

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05296733