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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Further inclusion criteria apply.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 360 hours
Awards & highlights
No Placebo-Only Group
Summary
This trial tests a drug called BI 456906, given as an injection, in adults with and without liver problems. It aims to see how liver issues affect the drug's absorption and tolerance. Participants include both healthy individuals and those who are overweight or obese.
Who is the study for?
Adults aged 18-75, with or without liver problems and varying body weights (BMI of 18.5-40 kg/m2), can join this study. It's for those who are healthy as well as people with overweight (BMI ≥27 kg/m2) or obesity. Women must use two effective contraception methods during the trial, and men need to meet a minimum weight requirement.
What is being tested?
The study tests BI 456906 in two parts: Part 1 checks how it's absorbed by healthy individuals versus those with liver issues after one injection; Part 2 examines tolerance to increasing doses over time in people with overweight/obesity, both with and without liver problems.
What are the potential side effects?
While not specified here, participants will be monitored for any health issues that arise during treatment which could include typical drug side effects such as nausea, headaches, allergic reactions or more specific effects related to BI 456906.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
Women who can become pregnant must use two effective methods of birth control during the study, including at least one method with a low failure rate. The study provides a list of birth control methods that meet these criteria. Oral contraceptives cannot be used during the treatment period.
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There are additional requirements you must meet to be included in this study.
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You must weigh at least 70 kg (154 lbs) if you are a female, and at least 80 kg (176 lbs) if you are a male.
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You are between 18 and 75 years old at the time of screening, or the legal age of consent if it's higher than 18.
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Your body mass index (BMI) is between 18.5 and 40.0.
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You have signed a document that explains the details of the study and agree to participate according to ethical and legal standards.
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If you are a woman who could become pregnant, you will not be eligible for the study unless you have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy (which permanently prevent pregnancy) or have gone without a period for 12 months without other medical reasons.
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You are between the ages of 18 and 75 years old.
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You are considered overweight or obese, which means your body mass index (BMI) is 27 or higher.
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You have provided a written consent form that states you understand and agree to participate in the trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 360 hours
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 360 hours
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Part A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)
Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)
Part B: Percentage of patients treated who experience treatment-emergent adverse event
Secondary study objectives
Part A: Percentage of patients treated who experience treatment-emergent adverse event
Side effects data
From 2021 Phase 2 trial • 413 Patients • NCT0415392924%
Diarrhoea
20%
Nausea
14%
Vomiting
12%
Decreased appetite
8%
Dyspepsia
8%
Headache
6%
Abdominal distension
6%
Abdominal pain upper
6%
Constipation
6%
Fatigue
4%
Eructation
4%
Flatulence
4%
Lipase increased
4%
Back pain
2%
Abdominal pain
2%
Gastrooesophageal reflux disease
2%
Asthenia
2%
Hypoglycaemia
2%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
BI 456906 0.3 mg
BI 456906 0.9 mg
BI 456906 1.8 mg
BI 456906 2.7 mg
BI 456906 1.2 Twice Weekly (2.4) mg
BI 456906 1.8 Twice Weekly (3.6) mg
Semaglutide
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: Part B: BI456906: Cohort 3Experimental Treatment1 Intervention
Patients with overweight/obesity with cirrhosis + CTP Class B
Group II: Part B: BI456906: Cohort 2Experimental Treatment1 Intervention
Patients with overweight/obesity with cirrhosis + CTP Class A
Group III: Part B: BI456906: Cohort 1Experimental Treatment1 Intervention
Patients with overweight/obesity without cirrhosis/hepatic impairment
Group IV: Part A: BI 456906: Cohort 4Experimental Treatment1 Intervention
Patients with cirrhosis + CTP Class C
Group V: Part A: BI 456906: Cohort 3Experimental Treatment1 Intervention
Patients with cirrhosis + CTP Class B
Group VI: Part A: BI 456906: Cohort 2Experimental Treatment1 Intervention
Patients with cirrhosis + Child-Turcotte-Pugh (CTP) Class A
Group VII: Part A: BI 456906: Cohort 1Experimental Treatment1 Intervention
Healthy subjects
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 456906
2017
Completed Phase 2
~1380
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for liver disease, such as ursodeoxycholic acid (UDCA) and obeticholic acid, work by improving bile flow and reducing liver inflammation. UDCA decreases cholesterol absorption and increases its catabolism into bile acids, which helps in conditions like primary biliary cholangitis.
Obeticholic acid activates the farnesoid X receptor, reducing bile acid production and liver inflammation. These mechanisms are crucial for liver disease patients as they help manage symptoms, slow disease progression, and improve liver function.
Understanding these mechanisms is important for developing new treatments like BI 456906, which aims to address similar issues in liver conditions and obesity.
Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.
Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,550 Previous Clinical Trials
15,857,426 Total Patients Enrolled
Zealand PharmaIndustry Sponsor
39 Previous Clinical Trials
3,270 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- There are additional requirements you must meet to be included in this study.You are considered overweight or obese, which means your body mass index (BMI) is 27 or higher.Your body mass index (BMI) is between 18.5 and 40.0.You have signed a document that explains the details of the study and agree to participate according to ethical and legal standards.If you are a woman who could become pregnant, you will not be eligible for the study unless you have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy (which permanently prevent pregnancy) or have gone without a period for 12 months without other medical reasons.You are between the ages of 18 and 75 years old.You have provided a written consent form that states you understand and agree to participate in the trial.Women who can become pregnant must use two effective methods of birth control during the study, including at least one method with a low failure rate. The study provides a list of birth control methods that meet these criteria. Oral contraceptives cannot be used during the treatment period.You must weigh at least 70 kg (154 lbs) if you are a female, and at least 80 kg (176 lbs) if you are a male.You are between 18 and 75 years old at the time of screening, or the legal age of consent if it's higher than 18.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: BI456906: Cohort 1
- Group 2: Part B: BI456906: Cohort 2
- Group 3: Part B: BI456906: Cohort 3
- Group 4: Part A: BI 456906: Cohort 1
- Group 5: Part A: BI 456906: Cohort 2
- Group 6: Part A: BI 456906: Cohort 3
- Group 7: Part A: BI 456906: Cohort 4
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Liver Disease Patient Testimony for trial: Trial Name: NCT05296733 — Phase 1
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