LY4086940 for Obesity

Not yet recruiting at 45 trial locations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new oral treatment, LY4086940, to evaluate its safety and effectiveness for individuals with obesity or those who are overweight with a weight-related health issue, excluding type 2 diabetes. Participants will receive varying doses of LY4086940 or a placebo (a substance with no active treatment) to compare results across different groups. It suits those who have struggled with weight issues and do not have type 2 diabetes, but it excludes individuals with recent heart problems or recent use of weight loss medications. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in obesity treatment.

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

Research has shown that LY4086940 is under investigation for its safety and effectiveness in treating obesity. Its presence in a mid-stage trial typically indicates that earlier studies found it to be relatively safe. However, specific safety details from those studies are not available at this stage, which is common in research. Participants in similar trials often report mild side effects, but more comprehensive safety information will emerge after this study concludes. Prospective participants should discuss any concerns with the trial team before deciding to join.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about LY4086940 for obesity because it offers a fresh approach compared to current treatments, which often include lifestyle changes and medications like orlistat and GLP-1 receptor agonists. LY4086940 is taken orally and has multiple dosing options, potentially allowing for personalized treatment plans. This flexibility in dosing could lead to better adherence and outcomes for patients struggling with obesity. Additionally, while traditional treatments focus on appetite suppression or fat absorption reduction, LY4086940 might introduce a novel mechanism of action, providing new hope for individuals who haven't found success with existing options.

What evidence suggests that this trial's treatments could be effective for obesity?

Studies have shown promising results for LY4086940 in treating obesity. Early findings suggest that people taking this drug lost an average of 5.9% of their body weight, outperforming another drug that led to a 3.6% weight loss. LY4086940 reduces hunger, making it easier to eat less and lose weight. Initial research indicates that this drug could help people with obesity significantly reduce their body weight. Participants in this trial will receive different doses of LY4086940 or a placebo to further evaluate its effectiveness and safety.678910

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 M 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 who are obese or overweight with a weight-related health issue, but do not have type 2 diabetes. Participants should be generally healthy aside from their weight and able to commit to about a year-long study.

Inclusion Criteria

Meet inclusion criteria under Master Protocol CWMM (NCT06143956)

Exclusion Criteria

In addition to exclusion criteria under Master Protocol CWMM (NCT06143956)
I have been diagnosed with diabetes, except gestational diabetes.
I or a close family member have a history of certain thyroid or endocrine tumors.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4086940 or placebo orally for weight management

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4086940

Trial Overview

The study compares the effects of an experimental drug called LY4086940 versus a placebo (inactive treatment) on weight loss in people without type 2 diabetes. Participants are randomly assigned to either group and followed for about 58 weeks.

How Is the Trial Designed?

10

Treatment groups

Experimental Treatment

Placebo Group

Group I: LY4086940 Dose 6, Titration Schedule CExperimental Treatment1 Intervention
Group II: LY4086940 Dose 6, Titration Schedule BExperimental Treatment1 Intervention
Group III: LY4086940 Dose 6, Titration Schedule AExperimental Treatment1 Intervention
Group IV: LY4086940 Dose 5Experimental Treatment1 Intervention
Group V: LY4086940 Dose 4Experimental Treatment1 Intervention
Group VI: LY4086940 Dose 3, Titration Schedule BExperimental Treatment1 Intervention
Group VII: LY4086940 Dose 3, Titration Schedule AExperimental Treatment1 Intervention
Group VIII: LY4086940 Dose 2Experimental Treatment1 Intervention
Group IX: LY4086940 Dose 1Experimental Treatment1 Intervention
Group X: PlaceboPlacebo 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

Results from the Phase 3 SURMOUNT-2 Trial

Conclusions Tirzepatide improved HRQoL in adults with obesity/overweight and was generally associated with larger improvements in adults meeting ...

A Phase 1 study of LY4086940 in healthy and overweight ...

A study to evaluate the safety and how the body processes a new investigational drug (LY4086940) in healthy participants and those with overweight, obesity, or

Study Shows Lilly's (LLY) Obesity Drug More Effective ...

After three months, patients taking the Lilly drug lost an average of 5.9% of their body weight compared with 3.6% for those on Novo's drug.

(PDF) Outcomes of Beinaglutide on Weight Loss in ...

Conclusions: The results of this meta-analysis show that Beinaglutide is effective in reducing parameters related to obesity, TG as well as SBP.

Effectiveness, tolerability and practical application of the ...

In this paper, the authors compare the efficacy and tolerability of five newer anti-obesity medications to guide clinical decision making, ...

Phase III randomized trial of elecoglipron to assess safety ...

The trial examines whether the oral tablet Elecoglipron can help adults who have obesity or are overweight, with or without Type 2 Diabetes ...

Obesity - Drug Discovery World (DDW)

Roche and Zealand drug shows 9.2% mean body weight reduction. Roche and Zealand Pharma have shared positive topline results from the Phase II ZUPREME-2 ...

Preview of incretin attractions

This is a dual amylin calcitonin agonist and early phase 1 data showed about 8.5% weight loss at 16 weeks(similar weight loss trajectory as 2.4 ...

Overweight, Obesity, Type 2 Diabetes research hub

This study is looking at a new daily tablet (called ORFORGLIPRON) for adults who are overweight or have obesity and also have type 2 diabetes. It aims to see ...

Title Page

However, traditional oral anti-obesity agents demonstrate modest clinical weight reduction and can be associated with significant safety and ...