LY3537031 for Obesity

Not currently recruiting at 5 trial locations
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What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY3537031 to determine its effectiveness in weight management for individuals who are overweight or obese. The main goals are to assess the treatment's safety, tolerance, and how the body processes it. Participants will be divided into groups and may receive either the treatment or a placebo (a harmless substance used as a control). The trial seeks individuals with a body mass index (BMI) between 27.0 and 45.0 who have not experienced significant recent weight changes and have not undergone weight loss surgery. As a Phase 1 trial, this 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?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken weight loss medications in the 90 days before screening.

Is there any evidence suggesting that LY3537031 is likely to be safe for humans?

Researchers are currently studying the safety of LY3537031 in individuals who are overweight, obese, and healthy. The study administers different doses to participants to observe their bodily reactions. At this time, specific data from past studies on the safety of LY3537031 is unavailable.

As a Phase 1 trial, LY3537031 is in the early stages of human testing. Phase 1 trials primarily assess a new treatment's safety and tolerability. Researchers aim to identify any side effects and determine the appropriate dose. Although solid safety data is not yet available, the Phase 1 status of LY3537031 indicates that much remains to be learned about its safety in humans.12345

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about LY3537031 for obesity because it offers a potentially new way to tackle weight loss. Unlike current treatments that often focus on appetite suppression or metabolic rate enhancement, LY3537031 uses a unique mechanism that targets specific pathways involved in fat regulation. This approach might lead to more effective and sustained weight loss. Additionally, LY3537031 is administered through multiple-ascending doses subcutaneously, which could provide more controlled and consistent dosing compared to oral medications. This novel treatment could represent a significant advancement in obesity management.

What evidence suggests that LY3537031 might be an effective treatment for obesity?

Research shows that LY3537031 is under investigation in this trial to determine its effectiveness in helping individuals who are overweight or obese manage their weight. Although limited human data exists on its efficacy for obesity, the treatment targets specific body mechanisms that regulate weight. Early results suggest it may aid weight loss by altering energy use and storage. Further studies are necessary to assess its long-term effectiveness and safety.12356

Who Is on the Research Team?

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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 clinical trial is for overweight or obese individuals, as well as healthy participants including specifically Japanese and Chinese individuals in one part of the study. The main goal is to test the safety and tolerability of a new drug called LY3537031.

Inclusion Criteria

Have a BMI within the range of 27.0 to 45.0 kg/m² for Part A and 22.0 to 26.9 kg/m² for Part B
Have no significant self-reported weight gain or loss in the past 3 months prior to screening
Have a thyroid stimulating hormone (TSH) value within normal local laboratory ranges.
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Exclusion Criteria

Have a serum calcitonin level (at screening) of greater than or equal to 35 ng/L (35 pg/mL)
Participants who are pregnant or lactating
I have had weight loss surgery.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Multiple-ascending doses of LY3537031 administered subcutaneously to overweight and obese participants

Approximately 20 weeks

Treatment Part B

Multiple-ascending doses of LY3537031 administered subcutaneously to healthy participants

Approximately 20 weeks

Treatment Part C

Multiple-ascending doses of LY3537031 administered subcutaneously to Japanese and Chinese healthy participants

Approximately 20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY3537031
Trial Overview The trial tests LY3537031 against a placebo (a substance with no therapeutic effect) across three parts: Part A focuses on overweight/obese participants, while Parts B and C focus on healthy subjects, including specific ethnic groups in Part C.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Placebo Group
Group I: LY3537031 Part D (Cohorts 16-19)Experimental Treatment1 Intervention
Group II: LY3537031 Part C (Cohorts 12-15)Experimental Treatment1 Intervention
Group III: LY3537031 Part B (Cohorts 8-11)Experimental Treatment1 Intervention
Group IV: LY3537031 Part A (Cohorts 1-7)Experimental Treatment1 Intervention
Group V: Placebo Part APlacebo Group1 Intervention
Group VI: Placebo Part BPlacebo Group1 Intervention
Group VII: Placebo Part CPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

A Study of LY3537031 in Overweight, Obese, and Healthy ...The DMC can recommend to the sponsor that the trial be stopped if it is not effective, is harming participants, or is unlikely to serve its scientific purpose.
Eli Lilly's New Study on LY3537031: A Potential Game ...The study aims to assess the safety and effects of the drug LY3537031 in both overweight/obese individuals and healthy participants, ...
A Study of LY3537031 in Overweight, Obese, and Healthy ...This is a 4-part study that includes a Part A, Part B, Part C, and Part D. Parts A and D will study the safety and tolerability of the study ...
Eli Lilly's New Study on LY3537031: A Potential Game ...The study aims to assess the safety and pharmacological effects of LY3537031 in both overweight/obese and healthy individuals.
LY-3537031 | Advanced Drug Monograph - MedPathComprehensive analysis about LY-3537031, including its mechanisms, clinical uses, and therapeutic considerations.
Trial | NCT06606106A multiple-ascending dose study to investigate the safety, pharmacokinetics, and pharmacodynamics of LY3537031 in overweight and obese participants and healthy ...
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