LY3532226 for Type 1 Diabetes

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must be taking: Insulin

Must not be taking: GLP-1 agonists, Metformin

Disqualifiers: Proliferative retinopathy, Childbearing potential, others

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if LY3532226 can help people with type 1 diabetes recover from low blood sugar caused by insulin by improving their body's glucagon response.

Will I have to stop taking my current medications?

You may need to stop taking certain medications like dipeptidyl peptidase-Ni, GLP-1 receptor agonists, GIP agonists, metformin, or sodium-glucose cotransporter 2 inhibitors if you've used them in the last 3 months. The trial does not specify about other medications, so it's best to discuss with the study team.

What data supports the effectiveness of the drug LY3532226 for Type 1 Diabetes?

The research highlights that immune therapies, including T-cell–directed therapies, have shown some success in preserving beta-cell function in type 1 diabetes, which is crucial for maintaining insulin production. Although no single therapy has been completely effective, combining immune modulation with other strategies may improve outcomes. ^{1 2 3 4 5}

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 adults with Type 1 Diabetes Mellitus (T1DM) who have been managing their condition with insulin for at least two years. They should have a BMI between 18.5 to 40 kg/m² and not be able to bear children. Those recently in other studies, on certain diabetes medications, or using steroids can't participate.

Inclusion Criteria

I have had type 1 diabetes for over 2 years and am on insulin.

Your body mass index (BMI) is between 18.5 and 40.0.

I am not able to have children.

Exclusion Criteria

Participation in another clinical study trial involving medical research, or participation within the last 30 days of screening in a clinical study involving a study intervention

I am a woman who could become pregnant.

I haven't taken diabetes medications like metformin or GLP-1 agonists in the last 3 months.

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 LY3532226 or placebo in a cross-over design to evaluate glucagon response to insulin-induced hypoglycemia

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3532226
• Placebo

Trial Overview The study tests LY3532226's effect on glucagon response during insulin-induced low blood sugar in T1DM patients compared to a placebo. It aims to see if the drug helps recover from low blood sugar better than no treatment over about four months.

How Is the Trial Designed?

Group I: LY3532226 Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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

Therapeutic interventions for type 1 diabetes aim to suppress harmful immune responses and restore beta-cell function, which is crucial for maintaining metabolic control.

Clinical trials have shown that both antigen-specific and non-specific immune therapies can provide short-term benefits in managing the autoimmune process, but no single long-term effective treatment has been found, suggesting that a combination of therapies may be necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevention of type 1 diabetes: today and tomorrow. Cernea, S., Dobreanu, M., Raz, I.[2017]

This study will evaluate the effects of the GLP-1 analogue liraglutide on pancreatic β-cell function in young individuals (ages 10-30) with early stages of type 1 diabetes, including those with multiple islet autoantibodies, over a 6-month period with follow-ups ranging from 6 to 18 months.

Liraglutide aims to support β-cell health and potentially reduce islet autoimmunity, contrasting with most prevention trials that focus solely on the immune system, thus providing a novel approach to managing early type 1 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). Kero, J., Koskenniemi, JJ., Karsikas, S., et al.[2022]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Treatment of recent-onset type 1 diabetic patients with DiaPep277: results of a double-blind, placebo-controlled, randomized phase 3 trial. [2014]

2. England pubmed.ncbi.nlm.nih.gov

Prevention of type 1 diabetes: today and tomorrow. [2017]

3. Germany pubmed.ncbi.nlm.nih.gov

Transforming type 1 diabetes: the next wave of innovation. [2022]

4. England pubmed.ncbi.nlm.nih.gov

INnoVative trial design for testing the Efficacy, Safety and Tolerability of 6-month treatment with incretin-based therapy to prevent type 1 DIAbetes in autoantibody positive participants: A protocol for three parallel double-blind, randomised controlled trials (INVESTDIA). [2022]

5. England pubmed.ncbi.nlm.nih.gov

Immune interventions to preserve β cell function in type 1 diabetes. [2018]