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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 96 hours postdose
Awards & highlights
Study Summary
This trial will test how well a drug is absorbed and cleared in people with normal or impaired liver function, and study its safety. It could last up to 6 weeks per person.
Who is the study for?
This trial is for men and women weighing at least 45 kg with a BMI of 18.5-40 kg/m², acceptable blood pressure and pulse rate, no significant hypoglycemia history, and controlled Type 2 diabetes (T2DM). It includes healthy individuals as well as those with mild to severe liver impairment (Child-Pugh Score A-C) who have had chronic hepatic impairment for over six months. Pregnant or breastfeeding women are excluded.Check my eligibility
What is being tested?
The study tests LY3502970 in participants with varying levels of liver function. It measures how much drug enters the bloodstream and the body's elimination time in people with impaired versus normal liver function. The safety and tolerability of LY3502970 will also be assessed during this up to six-week study.See study design
What are the potential side effects?
While specific side effects are not listed here, the trial will evaluate the safety and tolerability of LY3502970 which suggests monitoring for any adverse reactions such as issues related to medication intake, potential organ inflammation or other common drug-related problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ predose up to 96 hours postdose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 96 hours postdose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970
PK: Maximum observed concentration (Cmax) of LY3502970
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970
Side effects data
From 2022 Phase 2 trial • 383 Patients • NCT0504871938%
Nausea
21%
Vomiting
16%
Diarrhoea
13%
Constipation
9%
Fatigue
9%
Lipase increased
9%
Covid-19
7%
Gastrooesophageal reflux disease
7%
Dyspepsia
5%
Decreased appetite
5%
Abdominal distension
5%
Palpitations
4%
Eructation
4%
Arthralgia
4%
Weight decreased
4%
Urticaria
4%
Headache
2%
Muscle spasms
2%
Dizziness
2%
Hypertension
2%
Abdominal pain upper
2%
Upper respiratory tract infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
12 mg LY3502970
24 mg LY3502970
36 mg LY3502970 - 2
45 mg LY3502970 - 1
36 mg LY3502970 - 1
Placebo
3 mg LY3502970
45 mg LY3502970 - 2
1.5 mg Dulaglutide
Trial Design
4Treatment groups
Experimental Treatment
Group I: LY3502970 (Severe Hepatic Impairment)Experimental Treatment1 Intervention
LY3502970 administered orally.
Group II: LY3502970 (Normal Hepatic Function)Experimental Treatment1 Intervention
LY3502970 administered orally.
Group III: LY3502970 (Moderate Hepatic Impairment)Experimental Treatment1 Intervention
LY3502970 administered orally.
Group IV: LY3502970 (Mild Hepatic Impairment)Experimental Treatment1 Intervention
LY3502970 administered orally.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3502970
2021
Completed Phase 2
~1240
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,620 Previous Clinical Trials
3,216,566 Total Patients Enrolled
9 Trials studying Liver Failure
288 Patients Enrolled for Liver Failure
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,712 Total Patients Enrolled
8 Trials studying Liver Failure
252 Patients Enrolled for Liver Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I weigh at least 45 kg and my BMI is between 18.5 and 40.I have stable health conditions that won't affect the study.I have had pancreatitis, high amylase or lipase, or a GI disorder affecting stomach emptying.I do not have major heart, lung, liver, kidney, stomach, hormone, blood, or nerve disorders affecting drug processing.I have type 2 diabetes and liver issues, with my A1c between 5.0% and 11.0%.I have had chronic liver disease for over 6 months without major changes in the last 15 days.I have type 2 diabetes and liver issues but manage my diabetes with diet, exercise, or stable medication.I have liver issues but my blood hemoglobin level is at least 8.5 g/dL.I have type 2 diabetes and liver issues, but my lab tests are normal or not concerning.I am healthy or have liver disease but am considered fit for the study.I have only used metformin, sulfonylureas, or insulin for my diabetes in the past 6 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: LY3502970 (Mild Hepatic Impairment)
- Group 2: LY3502970 (Severe Hepatic Impairment)
- Group 3: LY3502970 (Normal Hepatic Function)
- Group 4: LY3502970 (Moderate Hepatic Impairment)
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this trial include individuals under the age of forty-five?
"Eligible participants for this medical trial must be over the age of majority and younger than 80 years old."
Answered by AI
How would LY3502970 (Mild Hepatic Impairment) impact patient safety?
"Our team at Power assigned a score of 1 to LY3502970 (Mild Hepatic Impairment) due to the limited clinical evidence available, as this is only in Phase 1 development."
Answered by AI
Is participation in this research project available to me?
"Candidates within the age range of 18-80 suffering from liver failure have a chance to take part in this trial. Approximately 30 individuals are required for the duration of this clinical study."
Answered by AI
Is recruitment still available for this trial?
"According to the information accessible on clinicaltrials.gov, this particular medical trial is no longer recruiting patients despite having been initially posted on June 16th 2023 and last updated on May 22nd 2023. However, 831 other trials are currently registering participants at present."
Answered by AI
Who else is applying?
What state do they live in?
Florida
What site did they apply to?
Orlando Clinical Research Center
Texas Liver Institute
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
Because I wanted to help make a difference in my life. I'm hoping to advance medical technology and knowledge and hopefully be part in approval of the vaccine at hand.
PatientReceived no prior treatments
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