LY3938577 for Type 2 Diabetes

No longer recruiting at 3 trial locations

Overseen By Nitendra Agarwal

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Sulfonylureas, Thiazolidinediones, Insulin, others

Disqualifiers: Proliferative retinopathy, Severe neuropathy, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of a new treatment called LY3938577 for people with Type 2 Diabetes (T2DM). The study consists of two parts: Part A involves a single dose, and Part B involves multiple doses. Participants will receive either LY3938577, insulin, or a placebo (a substance with no active drug) to compare effects. This trial suits those who have had Type 2 Diabetes for more than a year and are not currently on certain diabetes medications like insulin. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

If you are taking sulfonylurea, thiazolidinedione, alpha-glucosidase inhibitor, glucagon-like peptide-1 receptor agonist, or insulin, you must stop these medications at least 3 months before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that LY3938577 is being tested for safety and tolerability. This phase 1 trial marks the first step in testing the drug on humans. At this stage, researchers focus on the drug's safety and participants' reactions. Limited information exists about side effects because the studies are ongoing.

In phase 1 trials, researchers closely monitor participants for unexpected or harmful effects, such as headaches, nausea, or changes in blood sugar levels. However, specific side effects of LY3938577 have not been detailed yet. Participants receive careful monitoring to catch any problems early.

For those considering joining this trial, the main goal is to ensure the treatment's safety before wider testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Researchers are excited about LY3938577 for Type 2 Diabetes because it introduces a novel approach compared to standard treatments like metformin, sulfonylureas, and insulin. Unlike these traditional therapies, LY3938577 is an experimental drug administered subcutaneously, which offers a potentially new mechanism of action that could enhance glucose regulation in the body. This could lead to better management of blood sugar levels with possibly fewer side effects or improved convenience over daily insulin injections. Such innovation holds promise for improving the quality of life for individuals with Type 2 Diabetes.

What evidence suggests that this trial's treatments could be effective for Type 2 Diabetes?

Research has shown that LY3938577, a treatment under study in this trial, could be promising for people with Type 2 Diabetes. Previous participants experienced significant drops in fasting blood sugar levels and required less insulin with meals. Importantly, these benefits occurred without causing severe low blood sugar, suggesting LY3938577 might control blood sugar more effectively and safely. The treatment works differently from some traditional methods, aiming to better manage diabetes symptoms. ^{1 3 5 6 7}

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 healthy adults and those with Type 2 Diabetes Mellitus (T2DM). Healthy participants should have a BMI of 18.5-32 kg/m², while T2DM participants can have up to 40 kg/m². T2DM should be diagnosed over a year ago. People with severe eye or nerve complications, recent steroid therapy, or participation in another study recently cannot join.

Inclusion Criteria

I cannot become pregnant or get someone pregnant.

I am generally healthy as confirmed by a medical check-up.

My BMI is within the required range for my health status.

Exclusion Criteria

I have severe eye or nerve problems.

I have been on long-term steroid treatment in the last 3 months.

Are currently enrolled in another clinical study trial involving medical research, or have participated within the last 30 days in a clinical study involving an investigational product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment Part A

Participants receive a single dose of LY3938577 or placebo in healthy participants and participants with Type 2 Diabetes Mellitus

4 weeks

Treatment Part B

Participants with Type 2 Diabetes Mellitus receive multiple doses of LY3938577

10 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3938577

Trial Overview The safety and tolerability of LY3938577 are being tested on two groups: healthy individuals and those with T2DM. Part A involves a single dose for both types of participants; Part B gives multiple doses to only the T2DM group. The study compares LY3938577 against Insulin degludec and placebo over approximately six to ten weeks.

How Is the Trial Designed?

Group I: LY3938577 (Part B) Experimental Treatment 1 Intervention

LY3938577 administered SC.

Group II: LY3938577 (Part A) Experimental Treatment 1 Intervention

LY3938577 administered Subcutaneously (SC).

Group III: Insulin degludec (Part A) Active Control 1 Intervention

Insulin degludec administered SC.

Group IV: Insulin degludec (Part B) Active Control 1 Intervention

Insulin degludec administered SC.

Group V: Placebo (Part A) Placebo Group 1 Intervention

Placebo 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

Published Research Related to This Trial

In a 12-week study involving 72 adults with type 2 diabetes, the multi-receptor agonist LY3437943 demonstrated a good safety profile, with gastrointestinal disorders being the most common side effects.

LY3437943 significantly reduced daily plasma glucose and HbA1c levels, as well as body weight, in a dose-dependent manner, supporting its potential for once-weekly dosing and further development in treating type 2 diabetes and obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. Urva, S., Coskun, T., Loh, MT., et al.[2022]

In a phase 2 study involving 316 participants with poorly controlled type 2 diabetes, the dual receptor agonist LY3298176 demonstrated significantly better glucose control and weight loss compared to dulaglutide, with a dose-dependent reduction in HbA1c levels.

LY3298176 was generally well-tolerated, with gastrointestinal side effects being the most common but mostly mild to moderate, indicating a favorable safety profile for this new treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of LY3298176, a novel dual GIP and GLP-1 receptor agonist, in patients with type 2 diabetes: a randomised, placebo-controlled and active comparator-controlled phase 2 trial. Frias, JP., Nauck, MA., Van, J., et al.[2022]

LY2605541, a new basal insulin, was well-tolerated in patients with type 2 diabetes, showing a stable pharmacokinetic profile with minimal fluctuations and a duration of action lasting at least 24 hours.

The treatment led to significant reductions in fasting blood glucose levels and prandial insulin doses without causing severe hypoglycemia, indicating its efficacy and safety for managing diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steady-state pharmacokinetics and glucodynamics of the novel, long-acting basal insulin LY2605541 dosed once-daily in patients with type 2 diabetes mellitus. Sinha, VP., Howey, DC., Choi, SL., et al.[2022]

LY3298176, a dual GIP and GLP-1 receptor agonist, demonstrated significant improvements in glycemic control and body weight reduction in both preclinical studies and a Phase 1b trial involving 142 subjects with type 2 diabetes mellitus (T2DM).

The most common side effects were mild to moderate gastrointestinal issues, which were dose-dependent, indicating that while LY3298176 is effective, monitoring for these side effects is important during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Coskun, T., Sloop, KW., Loghin, C., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07215312

A Study of LY3938577 in Participants With Type 2 Diabetes ... Study Overview. The purpose of this study is to see how well LY3938577 works and how safe it is compared to degludec in people with type 2 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06132126

NCT06132126 | A Study to Investigate the Safety and ... The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 ...

3. withpower.com withpower.com/trial/phase-1-diabetes-mellitus-10-2023-8845e

LY3938577 for Type 2 Diabetes · Info for Participants The treatment led to significant reductions in fasting blood glucose levels and prandial insulin doses without causing severe hypoglycemia, indicating its ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/LLY/pressreleases/35389419/eli-lillys-new-diabetes-study-a-potential-game-changer/

Eli Lilly's New Diabetes Study: A Potential Game-Changer? The study aims to assess the efficacy and safety of LY3938577 compared to degludec in individuals with type 2 diabetes, highlighting its ...

5. trial.medpath.com trial.medpath.com/drug/report/f05bf474d0486f06

LY-3938577 | Advanced Drug Monograph - MedPath Comprehensive analysis about LY-3938577, including its mechanisms, clinical uses, and therapeutic considerations.

6. trialx.com trialx.com/clinical-trials/listings/262137/a-study-to-investigate-the-safety-and-tolerability-of-ly3938577-in-healthy-participants-and-participants-with-type-2-diabetes-mellitus/

Type 2 Diabetes Mellitus ) ( NCT06132126 ) Overview. The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and ...

7. trials.lilly.com trials.lilly.com/en-US/trial/436457.

A Study to Investigate the Safety and Tolerability ... - Lilly Trials The main purpose of this study is to assess the safety and tolerability of a single dose of LY3938577 in healthy participants and participants with Type 2 ...