Your session is about to expire
← Back to Search
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
Study Summary
This trial is testing a new drug, BI 456906, to see if it's safe and effective for people with liver problems. Healthy people and people with different levels of liver problems are both eligible to participate, and the trial has two parts. In the first part, doctors will test how BI 456906 is taken up in the body by different types of people. In the second part, participants will receive different doses of BI 456906 to see how well they tolerate it. The trial will last for 7 months total, and participants will visit the study site multiple times throughout.
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.Check my eligibility
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.See study design
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.
Select...
There are additional requirements you must meet to be included in this study.
Select...
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.
Select...
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.
Select...
Your body mass index (BMI) is between 18.5 and 40.0.
Select...
You have signed a document that explains the details of the study and agree to participate according to ethical and legal standards.
Select...
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.
Select...
You are between the ages of 18 and 75 years old.
Select...
You are considered overweight or obese, which means your body mass index (BMI) is 27 or higher.
Select...
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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Part A: Percentage of patients treated who experience treatment-emergent adverse event
Side effects data
From 2021 Phase 2 trial • 413 Patients • NCT0415392912%
Nausea
10%
Diarrhoea
8%
Hypoglycaemia
6%
Constipation
6%
Decreased appetite
6%
Lipase increased
4%
Eructation
4%
Vomiting
4%
Gastrooesophageal reflux disease
2%
Abdominal pain upper
2%
Dyspepsia
2%
Urinary tract infection
2%
Abdominal distension
2%
Fatigue
2%
Weight decreased
2%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Semaglutide
BI 456906 1.8 mg
BI 456906 2.7 mg
BI 456906 1.8 Twice Weekly (3.6) mg
Placebo
BI 456906 0.3 mg
BI 456906 0.9 mg
BI 456906 1.2 Twice Weekly (2.4) mg
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
~1290
Find a Location
Who is running the clinical trial?
Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,340,212 Total Patients Enrolled
Zealand PharmaIndustry Sponsor
37 Previous Clinical Trials
2,698 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
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals are part of this research endeavor?
"Correct. Online records on clinicaltrials.gov reveal that this research is currently recruiting with applications opening since April 27th 2022, and revised as recently as November 28th 2022. A total of 80 participants are sought from 3 separate locations."
Answered by AI
Are there still openings in this clinical trial for participants?
"Clinicaltrials.gov confirms that this trial is actively enrolling participants, having been initially posted on April 27th and recently updated November 28th of 2022."
Answered by AI
To what extent can BI 456906 be deleterious to human health?
"BI 456906 is considered to have a low degree of safety since it is only in Phase 1 trials, and there has been limited research done regarding efficacy. Therefore, the score for this drug was set at 1."
Answered by AI
Is there an age cutoff for applicants of this research project?
"This study is only open to patients aged 18-75. However, there are 294 trials for minors and 1260 for seniors."
Answered by AI
Which individuals are best suited for enrollment in this research trial?
"This clinical trial seeks 80 individuals between the ages of 18-75 who have been diagnosed with obesity. To be considered eligible, they must also meet a variety of criteria including: having a BMI between 18.5 and 40 kg/m2; providing written informed consent; being willing to use dual forms of contraception if female patients are still capable of childbirth; weighing 70kg or more for females, and 80kg or more for males at screening visit."
Answered by AI
Who else is applying?
What state do they live in?
Other
Texas
Arizona
Colorado
How old are they?
65+
18 - 65
What site did they apply to?
Covenant Metabolic Specialists, LLC
Other
American Research Corporation at the Texas Liver Institute
Arizona Liver Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
1
3+
0
What questions have other patients asked about this trial?
Is this a pay trail? How safe are the drugs? How long do i need to be in AZ?
PatientReceived 2+ prior treatments
Can you do this study from home? How long is trial for? And what does it pay?
PatientReceived no prior treatments
Why did patients apply to this trial?
I need to lose weight. I struggle with my weight. I have fibrosis 1 and obese.
PatientReceived 1 prior treatment
I am overweight and diabetic. To see what it’s about as Iam obese.
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 2 Days
Typically responds via
Phone Call
Most responsive sites:
- Covenant Metabolic Specialists, LLC: < 24 hours
- American Research Corporation at the Texas Liver Institute: < 48 hours
- Arizona Liver Health: < 48 hours
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger