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Monoclonal Antibodies

LY3437943 for Liver Function

Phase 1
Recruiting
Research Sponsored by Eli Lilly and Company
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 30 days postdose
Awards & highlights

Study Summary

This trial will measure how a drug affects people with mild, moderate, and severe liver problems, and test its safety and tolerability over 9 weeks.

Who is the study for?
This trial is for people with different levels of liver function, from healthy to severely impaired. Participants should have a body mass index (BMI) between 19.0 and 42.0 kg/m².Check my eligibility
What is being tested?
The study tests LY3437943 in individuals to see how much gets into the blood and how long it stays there across varying degrees of liver health. It also assesses the drug's safety over up to a nine-week period.See study design
What are the potential side effects?
While specific side effects are not listed, the trial will monitor participants for any adverse reactions or discomfort related to taking LY3437943.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 30 days postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 30 days postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK: Maximum observed concentration (Cmax) of LY3437943
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943

Side effects data

From 2022 Phase 2 trial • 281 Patients • NCT04867785
20%
Decreased appetite
20%
Nausea
15%
Diarrhoea
11%
Constipation
11%
Vomiting
11%
Upper respiratory tract infection
11%
Urinary tract infection
7%
Fatigue
7%
Dyspepsia
4%
Anaemia
4%
Covid-19
4%
Lipase increased
4%
Dizziness
4%
Weight decreased
2%
Cellulitis
2%
Diabetic ketoacidosis
2%
Abdominal pain
2%
Eructation
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
12 mg LY3437943 (2 mg)
8 mg LY3437943 (2 mg)
Placebo
1.5 Milligram (mg) Dulaglutide
0.5 mg LY3437943
4 mg LY3437943 (2 mg)
4 mg LY3437943 (4 mg)
8 mg LY3437943 (4 mg)

Trial Design

4Treatment groups
Experimental Treatment
Group I: LY3437943 (Severe Hepatic Impairment)Experimental Treatment1 Intervention
LY3437943 administered SC.
Group II: LY3437943 (Normal Hepatic Function)Experimental Treatment1 Intervention
LY3437943 administered subcutaneously (SC).
Group III: LY3437943 (Moderate Hepatic Impairment)Experimental Treatment1 Intervention
LY3437943 administered SC.
Group IV: LY3437943 (Mild Hepatic Impairment)Experimental Treatment1 Intervention
LY3437943 administered SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3437943
2022
Completed Phase 2
~950

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
3,216,562 Total Patients Enrolled
9 Trials studying Liver Failure
284 Patients Enrolled for Liver Failure
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,708 Total Patients Enrolled
8 Trials studying Liver Failure
248 Patients Enrolled for Liver Failure

Media Library

LY3437943 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05916560 — Phase 1
Liver Failure Research Study Groups: LY3437943 (Moderate Hepatic Impairment), LY3437943 (Severe Hepatic Impairment), LY3437943 (Normal Hepatic Function), LY3437943 (Mild Hepatic Impairment)
Liver Failure Clinical Trial 2023: LY3437943 Highlights & Side Effects. Trial Name: NCT05916560 — Phase 1
LY3437943 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05916560 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research endeavor allow those younger than sixty years old to participate?

"The minimum age for inclusion in this medical trial is 18, while the upper limit of 85 years old has been stipulated as an eligibility criterion."

Answered by AI

Are new participants being invited to join this experiment?

"Unfortunately, as indicated on clinicaltrials.gov, this medical research is not currently in need of participants. The trial was initially posted to the website on June 30th 2023 and had its most recent update a fortnight later; however 838 other studies are actively seeking volunteers right now."

Answered by AI

Could I potentially qualify to participate in this research?

"This medical trial is currently accepting applications from individuals between 18 and 85 years old with liver failure. As of now, 37 patients have been enrolled."

Answered by AI

What kind of impacts does LY3437943 (Normal Hepatic Function) pose to humans?

"As this is an early-stage trial, limited safety and efficacy data exists for LY3437943 (Normal Hepatic Function), thus it has been given a rating of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of LY3437943 in Participants With Impaired and Normal Liver Function
2023. "A Study of LY3437943 in Participants With Impaired and Normal Liver Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05916560.
~13 spots leftby Oct 2024
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