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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

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ClinicalTrials.gov Identifier: NCT05296733
Recruitment Status : Recruiting
First Posted : March 25, 2022
Last Update Posted : March 7, 2023
Sponsor:
Collaborator:
Zealand Pharma
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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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.


Condition or disease Intervention/treatment Phase
Healthy Liver Diseases Obesity Drug: BI 456906 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 27, 2022
Estimated Primary Completion Date : December 22, 2023
Estimated Study Completion Date : December 22, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Part A: BI 456906: Cohort 1
Healthy subjects
 Drug: BI 456906
BI 456906
Experimental: Part A: BI 456906: Cohort 2
Patients with cirrhosis + Child-Turcotte-Pugh (CTP) Class A
 Drug: BI 456906
BI 456906
Experimental: Part A: BI 456906: Cohort 3
Patients with cirrhosis + CTP Class B
 Drug: BI 456906
BI 456906
Experimental: Part A: BI 456906: Cohort 4
Patients with cirrhosis + CTP Class C
 Drug: BI 456906
BI 456906
Experimental: Part B: BI456906: Cohort 1
Patients with overweight/obesity without cirrhosis/hepatic impairment
 Drug: BI 456906
BI 456906
Experimental: Part B: BI456906: Cohort 2
Patients with overweight/obesity with cirrhosis + CTP Class A
 Drug: BI 456906
BI 456906
Experimental: Part B: BI456906: Cohort 3
Patients with overweight/obesity with cirrhosis + CTP Class B
 Drug: BI 456906
BI 456906


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. Part A: Maximum measured concentration of BI 456906 in plasma (Cmax) [ Time Frame: Up to 360 hours ]
  3. Part B: Percentage of patients treated who experience treatment-emergent adverse event [ Time Frame: Up to Day 218 ]

Secondary Outcome Measures :
  1. Part A: Percentage of patients treated who experience treatment-emergent adverse event [ Time Frame: Up to Day 35 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05296733


Contacts
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Contact: Boehringer Ingelheim 1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations
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United States, Arizona
Arizona Liver Health Recruiting
Chandler, Arizona, United States, 85224
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Florida
Covenant Metabolic Specialists, LLC Recruiting
Fort Myers, Florida, United States, 33912
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Covenant Metabolic Specialists, LLC Recruiting
Sarasota, Florida, United States, 34240
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
United States, Texas
American Research Corporation at the Texas Liver Institute Recruiting
San Antonio, Texas, United States, 78215
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
IMA Clinical Research San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Boehringer Ingelheim    833-602-2368    unitedstates@bitrialsupport.com   
Germany
Universitätsklinikum Bonn AöR Recruiting
Bonn, Germany, 53127
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Universitätsklinikum Ulm Recruiting
Ulm, Germany, 89081
Contact: Boehringer Ingelheim    08007234742    deutschland@bitrialsupport.com   
Hungary
Semmelweis University Recruiting
Budapest, Hungary, 1083
Contact: Boehringer Ingelheim    680017725    magyarorszag@bitrialsupport.com   
CRU Hungary Ltd. Recruiting
Kistarcsa, Hungary
Contact: Boehringer Ingelheim    680017725    magyarorszag@bitrialsupport.com   
New Zealand
New Zealand Clinical Research (NZCR) Recruiting
Auckland, New Zealand, 1010
Contact: Boehringer Ingelheim    0800440725    newzealand@bitrialsupport.com   
Poland
Dr. Piotr Napora, Center of Clinical Research Recruiting
Wroclaw, Poland, 51162
Contact: Boehringer Ingelheim    008001218830    polska@bitrialsupport.com   
Sponsors and Collaborators
Boehringer Ingelheim
Zealand Pharma
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT05296733    
Other Study ID Numbers: 1404-0010
2021-006247-10 ( EudraCT Number )
First Posted: March 25, 2022    Key Record Dates
Last Update Posted: March 7, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to:

https://www.mystudywindow.com/msw/datatransparency

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Obesity
Overweight
Overnutrition
 Nutrition Disorders
Body Weight
Digestive System Diseases