108 Participants NeededMy employer runs this trial

LY4174794 for Obesity

Recruiting at 2 trial locations
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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 assess the safety and tolerability of a new treatment called LY4174794 for individuals who are overweight or have obesity. Researchers will evaluate how the body processes the treatment by analyzing blood tests. Participants will receive the treatment either through an injection under the skin or an IV, while some will receive a placebo (a non-active substance). This study is suitable for individuals who are generally healthy, have a BMI of 27 or higher, and have maintained a stable weight for at least three months. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that LY4174794 is likely to be safe for humans?

Research has shown that LY4174794 is under study as a treatment for obesity. Similar drugs, like retatrutide, often cause side effects such as nausea, diarrhea, and irregular heartbeats, which have been observed in some individuals taking the drug. These effects are common with this type of treatment.

Previous studies suggest that stomach and intestinal issues are the most frequent side effects. So far, LY4174794 has not presented any unexpected safety concerns compared to similar treatments. Since this trial is in the early stages, it primarily focuses on understanding how well participants tolerate the drug. Researchers are closely monitoring and studying any potential side effects.

In summary, while LY4174794 aims to aid weight loss, it may cause some side effects, mostly related to the stomach and intestines. Participants should consider these factors when deciding whether to join the trial.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about LY4174794 for obesity because it offers a novel approach compared to standard treatments like lifestyle changes, medications such as orlistat, and GLP-1 receptor agonists like semaglutide. LY4174794 is unique because it can be administered both subcutaneously and intravenously, providing flexibility in how patients receive treatment. This dual administration method could potentially enhance patient compliance and effectiveness, making it a promising candidate in the fight against obesity. Moreover, the specific mechanism of action and active ingredients in LY4174794 might offer advantages over current options, potentially leading to improved weight loss outcomes.

What evidence suggests that LY4174794 might be an effective treatment for obesity?

Research shows that treatments like LY4174794 have potential for aiding weight loss. For example, a similar drug, retatrutide, helped participants lose significant weight in studies. In one study, participants lost up to 28.3% of their body weight over approximately 80 weeks. This trial will test LY4174794 for obesity, and it may also promote weight loss. Although the exact mechanism of LY4174794 in humans is still under investigation, its development is based on positive results from similar treatments.26789

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 trial is for adults who are overweight (BMI ≥27) or have obesity (BMI ≥30), are otherwise healthy, and have had a stable weight for at least 3 months. People with major health issues or women who could become pregnant cannot join.

Inclusion Criteria

Are overtly healthy with no comorbidities related to body mass index (BMI), such as type 2 diabetes mellitus or unstable cardiovascular disease
Are overweight with a BMI of ≥27 kilogram per meter square (kg/m²), or have obesity with a BMI of ≥30 kg/m²
Have had a self-reported stable weight for 3 months prior to screening

Exclusion Criteria

Is an individual of childbearing potential (IOCBP)
I have serious health problems that could affect how my body handles medication.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive LY4174794 or placebo administered subcutaneously or intravenously

21-35 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • LY4174794

Trial Overview

The study is testing the safety and how the body processes a new drug called LY4174794 compared to a placebo in people with obesity or overweight. Participants will be randomly assigned to receive either LY4174794 or placebo over about 7–11 months.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Part C: LY4174794Experimental Treatment1 Intervention
Group II: Part B: LY4174794Experimental Treatment2 Interventions
Group III: Part A: LY4174794Experimental Treatment2 Interventions
Group IV: Part A & 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

Eli Lilly weight loss drug retatrutide clears obesity trial

The highest dose of retatrutide helped patients lose 28.3% of their weight — or 70.3 pounds — on average over 80 weeks.

A glimpse into the pipeline of anti-obesity medication ... - PMC

The 64-week OASIS 4 trial reports outcomes in a similar population using a maximum dose of 25 mg, which produces a mean weight loss of 13.6% compared to 2.2% ...

Lilly's triple agonist, retatrutide, delivered powerful weight ...

12 mg retatrutide lost an average of 70.3 lbs (28.3%) over 80 weeks with 45.3% of participants achieving ≥30% weight loss, average of 85.0 lbs

Lilly's obesity triple threat tops phase 3 efficacy forecasts

After 68 weeks of once-weekly injections, patients on the higher 12-mg dose of retatrutide lost an average of 28.7% of their body weight,

Study Details | NCT06383390 | The Effect of Retatrutide ...

The main purpose of this study is to determine if retatrutide can significantly lower the incidence of serious heart-related complications or prevent the ...

Lilly shares safety, tolerability data on its next-gen obesity ...

New data showed that seven out of the 403 participants who received retatrutide experienced arrhythmias (irregular heartbeats), and three ...

Safety and Tolerability of LY4174794 in Healthy ...

This phase 1 study aims to evaluate the safety and tolerability of LY4174794 in healthy overweight or obese individuals by monitoring the number of participants

A Study of LY3841136 in Overweight and Obese Participants

The main purpose of this study is to assess the safety and tolerability of LY3841136 when administered in combination with tirzepatitide in overweight and obese ...

A Commentary on the Novel Triagonist Retatrutide for Obesity

The most common adverse effects were gastrointestinal. anticipated in November 2025. Caution should be exercised when using retatrutide with ...