LY3437943 for Liver Function

Recruiting at 5 trial locations

Overseen By Madhavi Rudraraju

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Organ transplant, Ascites, Variceal bleeding, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

43 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3437943 (Retatrutide) to understand its behavior in the body, particularly its absorption into the bloodstream and duration of presence. Researchers compare results among individuals with varying liver function, from healthy to severely impaired. The trial also assesses the treatment's safety and tolerability. Ideal participants may have liver function issues but should not be expecting an organ transplant soon or require frequent medical procedures for their condition. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive it.

Is there any evidence suggesting that LY3437943 is likely to be safe for humans?

Research has shown that LY3437943, also known as retatrutide, is generally well-tolerated. In earlier studies, this treatment did not consistently affect liver function or other fat levels in the blood, suggesting it is safe for the liver. Specifically, one study found that 9 out of 10 patients with non-alcoholic fatty liver disease (NAFLD) had their liver fat levels return to normal after 48 weeks of treatment.

While these results are promising, LY3437943 remains in the early stages of testing for liver safety, so more information is needed to fully understand its safety. However, current evidence suggests it is a safe option for those considering joining a clinical trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for liver function issues, which often focus on managing symptoms or slowing disease progression, LY3437943 offers a novel approach by potentially improving liver function directly. Researchers are excited about this treatment because it is administered subcutaneously, which could enhance patient compliance compared to oral or intravenous options. Additionally, LY3437943 is being studied for its effectiveness across different levels of hepatic impairment, from mild to severe, which could make it a versatile option for a broad range of patients. This unique feature sets it apart from traditional therapies that may not cater to varying degrees of liver function impairment.

What evidence suggests that LY3437943 might be an effective treatment for liver function?

Research has shown that LY3437943 may benefit liver health. Studies have found that it can reduce liver fat and enhance liver function. Specifically, it has reduced liver triglycerides (a type of fat) and lowered levels of alanine aminotransferase, an enzyme indicating liver health. These changes suggest that LY3437943 could aid individuals with liver issues. Early results also indicate it can assist with weight loss, which benefits liver conditions. Participants in this trial will receive LY3437943, with different arms assessing its effects on individuals with varying degrees of hepatic impairment. ^{1 2 3 4 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am healthy or have liver issues depending on the study's needs.

All Participants must have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive

Exclusion Criteria

I have liver issues and am expecting a transplant soon.

I don't need a procedure to remove excess belly fluid more than twice a month.

I haven't had variceal bleeding in the last 3 months, or if I did, it was successfully treated over a month ago.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of LY3437943 administered subcutaneously

1 day

Follow-up

Participants are monitored for safety and pharmacokinetics of LY3437943

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3437943

Trial Overview 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.

How Is the Trial Designed?

Group I: LY3437943 (Severe Hepatic Impairment) Experimental Treatment 1 Intervention

LY3437943 administered SC.

Group II: LY3437943 (Normal Hepatic Function) Experimental Treatment 1 Intervention

LY3437943 administered subcutaneously (SC).

Group III: LY3437943 (Moderate Hepatic Impairment) Experimental Treatment 1 Intervention

LY3437943 administered SC.

Group IV: LY3437943 (Mild Hepatic Impairment) Experimental Treatment 1 Intervention

LY3437943 administered SC.

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05916560

NCT05916560 | A Study of LY3437943 in Participants With ... The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa2301972

Triple–Hormone-Receptor Agonist Retatrutide for Obesity In adults with obesity, retatrutide treatment for 48 weeks resulted in substantial reductions in body weight.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11271400/

Triple hormone receptor agonist retatrutide for metabolic ... Liver fat reduction of at least 50% and at least 70% was achieved by 43–100% and 32–93% of participants who received retatrutide, respectively ( ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41025003/

Efficacy and safety of anti-obesity drugs in metabolic ... Efficacy and safety of anti-obesity drugs in metabolic dysfunction-associated steatotic liver disease: An updated review.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1550413122003126

LY3437943, a novel triple glucagon, GIP, and GLP-1 ... LY improved liver health as demonstrated by a decrease in plasma alanine aminotransferase and liver triglycerides (Figures 2I and 2J). In an ...

6. professional.diabetes.org professional.diabetes.org/sites/default/files/media/embargoed_ada_sci_sessions_2023_news_release_retatrutide.pdf

News Release Findings showed that in those with NAFLD, the amount of fat in the liver normalized in 9 out of 10 patients after 48 weeks treatment with the ...