LY3938577 for Type 2 Diabetes

Recruiting at 25 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Eli Lilly and Company

Must be taking: Basal insulin

Disqualifiers: Type 1 diabetes

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3938577, an experimental therapy, to evaluate its efficacy and safety for people with type 2 diabetes. The study compares LY3938577 to an existing insulin treatment known as degludec. Participants will be involved for about 26 weeks. Suitable candidates for this trial have type 2 diabetes, currently use a specific amount of insulin daily, and have a body mass index (BMI) between 20 and 35. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, since it involves comparing LY3938577 to degludec, you might need to continue your current insulin regimen.

Is there any evidence suggesting that LY3938577 is likely to be safe for humans?

Research has shown that LY3938577 has been tested in studies involving both healthy individuals and those with Type 2 Diabetes. These studies evaluated the treatment's tolerability and safety. Although detailed results from these studies are not available, they suggest that LY3938577 is undergoing safety assessments in humans.

Currently, this trial is in the early stages of human testing. Researchers are still learning about its safety and potential side effects. At this stage, there may be limited information on how well participants tolerate LY3938577. However, advancing to this phase indicates sufficient initial safety data to proceed with testing. Participants can expect the trial to closely monitor for any adverse effects as researchers gather more information about LY3938577's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 2 diabetes?

LY3938577 is unique because it offers a new approach to treating Type 2 Diabetes through its experimental nature. Unlike standard treatments such as metformin or insulin analogs, LY3938577 is administered subcutaneously and potentially works through a different mechanism. Researchers are excited about its potential to improve blood sugar control in a more targeted manner, which could lead to better outcomes for patients. This fresh approach might provide an alternative for those who haven't responded well to existing therapies.

What evidence suggests that LY3938577 might be an effective treatment for type 2 diabetes?

In this trial, participants will receive either LY3938577 or degludec. Previous studies have shown that LY3938577 holds promise in treating type 2 diabetes. Specifically, participants in those studies experienced significant drops in fasting blood sugar levels and required less insulin with meals after taking LY3938577. This suggests that LY3938577 might effectively help control blood sugar in people with type 2 diabetes. ^{1 3 4 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 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 individuals with type 2 diabetes who have previously been treated with basal insulin. The study will last approximately 26 weeks, and participants must meet certain health criteria to join.

Inclusion Criteria

I have type 2 diabetes.

My BMI is between 20 and 35.

I take 20-55 units of basal insulin daily, not exceeding 1.5 units/kg.

Exclusion Criteria

I have type 1 diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY3938577 or degludec subcutaneously for the duration of the study

26 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 study aims to compare the effectiveness and safety of a new medication called LY3938577 against Degludec, an existing treatment for type 2 diabetes.

How Is the Trial Designed?

Group I: LY3938577 Experimental Treatment 1 Intervention

Participants will receive LY3938577 subcutaneously (SC)

Group II: Degludec Active Control 1 Intervention

Participants will receive degludec 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/NCT07215312

NCT07215312 | A Study of LY3938577 in Participants With ... 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 diabetes. Participation in the study ...

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

LY3938577 for Type 2 Diabetes · Info for Participants Previous participants experienced significant drops in fasting blood sugar levels and required less insulin with meals.

3. 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 ...

4. 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 ...

5. trial.medpath.com trial.medpath.com/clinical-trial/b995ffcaefb69e35/nct07215312-ly3938577-type-2-diabetes-basal-insulin

A Study of LY3938577 in Participants With Type 2 Diabetes ... 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 diabetes.

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

LY-3938577 | Advanced Drug Monograph - MedPath It is in Phase I clinical trials for the treatment of Type 1 Diabetes Mellitus (T1DM) and Type 2 Diabetes Mellitus (T2DM).[1] The primary ...