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

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Boehringer Ingelheim
Study ID
NCT05296733
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • BI 456906 — DRUG
    BI 456906

Study Details

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.

Key Dates

Start date
Apr 27, 2022
Status verified
Aug 2024
Primary completion
Dec 29, 2023
Completion
Dec 29, 2023

Study Design

Enrollment
82 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

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 ]

Locations (5)

FacilityCityStateZIPSite coordinators
Arizona Liver HealthChandlerArizona85224-
Covenant Metabolic Specialists, LLCFort MyersFlorida33912-
Covenant Metabolic Specialists, LLCSarasotaFlorida34240-
American Research Corporation at the Texas Liver InstituteSan AntonioTexas78215-
IMA Clinical Research San AntonioSan AntonioTexas78229-

Find similar trials in Chandler, AZ

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Obesity / overweight
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By research site
Arizona Liver Health· Chandler, AZCovenant Metabolic Specialists, LLC· Fort Myers, FLCovenant Metabolic Specialists, LLC· Sarasota, FLAmerican Research Corporation at the Texas Liver Institute· San Antonio, TXIMA Clinical Research San Antonio· San Antonio, TX

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