144 Participants Needed

LY4064912 for Obesity

(YHAA Trial)

Recruiting at 2 trial locations
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Tq
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Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Eli Lilly and Company

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well the experimental treatment LY4064912 is tolerated and what side effects it might cause in individuals with overweight or obesity. Participants will receive the treatment either under the skin or into a vein, while some will receive a placebo (a substance with no active drug). The trial will monitor how the body processes the drug and its effects. Ideal candidates for this trial have maintained a stable weight for at least three months and meet specific BMI criteria, such as a BMI between 27 and 45 for Part B. 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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LY4064912 is likely to be safe for humans?

Research has shown that LY4064912 is being tested to assess its safety in people. Studies have found that it can be administered either under the skin (subcutaneously) or directly into the vein (intravenously). The goal is to evaluate how well people tolerate it and to identify any side effects.

Reports indicate that the most common side effects involve the stomach, such as nausea and diarrhea, and these are usually mild to moderate. As this is a Phase 1 study, understanding of the treatment's safety is still in the early stages. Phase 1 trials primarily focus on safety, so information on long-term effects remains limited.

In summary, LY4064912 has shown some mild stomach-related side effects, but further research is needed to fully understand its safety.12345

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

Researchers are excited about LY4064912 for obesity because it offers a new approach by being administered both subcutaneously and intravenously, allowing for flexible dosing options. Unlike other treatments that often require oral administration or lifestyle changes, LY4064912's delivery methods can cater to different patient needs and preferences. Additionally, while many existing obesity treatments focus on appetite suppression or metabolic rate enhancement, LY4064912 may have a unique mechanism of action that sets it apart, though specific details are still under investigation. This potential for a novel approach is a key reason for the excitement surrounding this treatment.

What evidence suggests that LY4064912 could be an effective treatment for obesity?

Research shows that LY4064912 is under investigation as a possible treatment for obesity in this trial. Although information on LY4064912 remains limited, it is being studied for its potential to aid weight loss. Early signs suggest it may work by altering the body's energy use, potentially leading to weight loss. Other drugs in similar studies have demonstrated significant weight loss, with some participants losing up to 11.2% of their weight at certain doses. These findings suggest that LY4064912 could effectively treat obesity, but further research is necessary to confirm this.12346

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 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 healthy individuals as well as those who are overweight or obese. Participants will receive the study drug LY4064912 either under their skin or directly into a vein in their arm.

Inclusion Criteria

Safety laboratory tests are within normal reference range
Part A: Body Mass Index (BMI) within the range greater than or equal to 21 and less than 30 kilogram per square meter (kg/m²)
Part B: Body Mass Index (BMI) greater than or equal to 27 and less than 45 kg/m²
See 5 more

Exclusion Criteria

Are individuals of childbearing potential (IOCBP)
I have diabetes or my HbA1c level is 6.5% or higher.
I don't have major health issues that could affect drug processing or pose risks with the study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4064912 or placebo administered subcutaneously or intravenously

Up to 11 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 16 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4064912
Trial Overview The trial is testing LY4064912 to see how it's tolerated and its side effects when given subcutaneously or intravenously. It also looks at how the body processes this drug and its impact on bodily functions through blood tests.
How Is the Trial Designed?
7Treatment groups
Experimental Treatment
Placebo Group
Group I: Part C: PlaceboExperimental Treatment1 Intervention
Group II: Part C: LY4064912 (Cohort 11)Experimental Treatment1 Intervention
Group III: Part B: LY4064912 (Cohorts 7-10)Experimental Treatment1 Intervention
Group IV: Part A: LY4064912 (Cohorts 1-6)Experimental Treatment1 Intervention
Group V: Part A: LY4064912 (Cohort 4b)Experimental Treatment1 Intervention
Group VI: Part A: PlaceboPlacebo Group1 Intervention
Group VII: Part B: 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

A Study of LY4064912 in Healthy Participants and With ...The purpose of this study is to evaluate how well LY4064912 is tolerated and what side effects may occur in healthy participants and ...
Eli Lilly's New Obesity Drug Study: Key Insights for InvestorsEli Lilly and Company is conducting a Phase 1 clinical study titled 'A Study of LY4064912 in Healthy Participants and With Overweight or Obesity ...
LY4064912 for Obesity (YHAA Trial)The purpose of this study is to evaluate how well LY4064912 is tolerated and what side effects may occur in healthy participants and participants with ...
Eli Lilly's LY4064912: A New Obesity Drug CandidateKey Points: - Efficacy: Participants taking Orforglipron experienced weight loss up to 11.2% at a 36 mg dose, compared to a 2.1% reduction in ...
Eli Lilly's New Obesity Drug Study: Key Insights for InvestorsThis research is significant as it explores potential treatments for obesity-related conditions. The intervention being tested is LY4064912, ...
LY 4064912 - AdisInsight - SpringerLY 4064912 is being developed by Eli Lilly and Company for the treatment of the obesity. Clinical development is underway in US and ...
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