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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates a new drug, LY3532226, to determine if it helps people with type 1 diabetes recover from insulin-induced low blood sugar. The trial compares the effects of LY3532226 to a placebo (a harmless pill with no active drug). Individuals who have had type 1 diabetes for at least two years and are on insulin might be suitable candidates for this study. The trial lasts around 16 weeks, excluding the initial screening period. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that LY3532226 is likely to be safe for humans?

Research has shown that LY3532226 is being tested to help people with type 1 diabetes manage low blood sugar caused by insulin. Although limited safety information about LY3532226 exists, it is important to note that this trial is in its early stages. Early trials primarily assess safety, so any major side effects would likely be identified during this phase. This suggests that the treatment appears generally safe so far. However, as this is a new drug being tested in people, participants should understand that its safety is still under study. Discussing any concerns with the trial team or a healthcare provider before joining is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 1 diabetes?

Unlike the standard treatments for Type 1 Diabetes, which typically include insulin therapy and blood sugar monitoring, LY3532226 is unique because it may offer a new approach to managing the condition. Researchers are excited about LY3532226 as it targets an innovative mechanism that could potentially improve blood sugar control in a different way than insulin. This novel angle could mean more effective management of blood glucose levels with potentially fewer side effects, making it a promising option for patients.

What evidence suggests that LY3532226 might be an effective treatment for type 1 diabetes?

Research shows that LY3532226, which participants in this trial may receive, might help people with type 1 diabetes recover from low blood sugar by boosting the body's glucagon response. Glucagon, a hormone that raises blood sugar levels, can prevent low blood sugar caused by insulin when its response improves. Early studies suggest that LY3532226 supports this process, offering promise for managing blood sugar levels in type 1 diabetes. Although detailed human data remains limited, focusing on the glucagon response shows potential in addressing low blood sugar challenges. ^{1 2 3 5 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 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. clinicaltrials.gov clinicaltrials.gov/study/NCT05887999

NCT05887999 | A Study of LY3532226 in Participants With ... The main purpose of this study is to evaluate the response of glucagon to insulin-induced low blood sugar after administration of the study drug LY3532226 in ...

2. withpower.com withpower.com/trial/phase-1-diabetes-mellitus-5-2023-cd26b

LY3532226 for Type 1 Diabetes · Info for Participants 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.

3. trials.lilly.com trials.lilly.com/en-US/find/completed

Completed Trials - Lilly Trials A Study of LY3532226 in Participants With Type 1 Diabetes Mellitus. Conditions: Type 1 Diabetes. The main purpose of this study is to evaluate the response of ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07215559

A Study of Macupatide (LY3532226) and Eloralintide ... The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity ...

5. trials.lilly.com trials.lilly.com/en-US/trial/407539

A Study of LY3532226 in Participants With Type 1 ... - Lilly Trials The main purpose of this study is to evaluate the response of glucagon to insulin-induced low blood sugar after administration of the study drug LY3532226.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36268825/

Clinical and Safety Outcomes With GLP-1 Receptor ... After 1 year of therapy, GLP-1RA users had statistically significant reductions in weight (90.5 kg to 85.4 kg; P < .001), glycated hemoglobin ...