What is the mechanism of action of this treatment?

Common treatments for obesity include glucagon-like peptide-1 (GLP-1) receptor agonists like liraglutide and semaglutide, which work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, leading to reduced appetite and increased satiety. Phentermine-topiramate combines an appetite suppressant with an anticonvulsant to promote weight loss. These mechanisms are crucial for obesity patients as they address the physiological aspects of hunger and satiety, making it easier to adhere to a reduced-calorie diet and achieve significant weight loss. The focus on safety and tolerability, as seen in the LY3841136 study, ensures that these treatments can be used long-term without adverse effects, which is essential for sustained weight management.

What side effects are associated with this type of intervention?

Common treatments for obesity, such as GLP-1 receptor agonists and phentermine/topiramate combinations, have several known side effects. GLP-1 receptor agonists can cause gastrointestinal issues like nausea, vomiting, and diarrhea, and there is a potential risk for pancreatitis and gallbladder disease. Phentermine/topiramate combinations often lead to dry mouth, paresthesia, constipation, insomnia, and dizziness. Both treatments are generally well-tolerated but require monitoring for these adverse effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including phentermine-topiramate, liraglutide, and lorcaserin. Phentermine-topiramate is a combination that has shown significant weight loss in clinical trials. Liraglutide, a GLP-1 receptor agonist, is also approved for weight management and has demonstrated efficacy in reducing body weight. Lorcaserin was previously approved but was withdrawn from the market due to concerns about an increased risk of cancer. These treatments focus on appetite suppression and metabolic regulation, similar to the goals of the LY3841136 study, which aims to assess the safety and tolerability of a new obesity treatment.

What other types of research exist?

Promising alternatives to LY3841136 for obesity treatment in 2024 include: 1) Semaglutide, a GLP-1 receptor agonist, which has shown significant weight loss in clinical trials. 2) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has demonstrated superior weight reduction compared to other treatments. 3) Setmelanotide, a melanocortin 4 receptor agonist, specifically for patients with genetic obesity disorders. These alternatives have shown promising results in terms of efficacy and safety in recent studies.

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LY3841136 for Obesity

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose through week 14 (part a) & week 28 (part b)

Summary

This trial is testing a new drug called LY3841136 to see if it is safe and well-tolerated. It involves healthy and overweight participants. Blood tests will be used to measure how much of the drug gets into the bloodstream and how long it takes for the body to get rid of it.

Who is the study for?

This trial is for healthy or overweight males and non-childbearing potential females with a stable weight. Participants must have a BMI of 18.5-32 kg/m² (Part A) or 27-40 kg/m² (Part B). They should agree to use contraception. Those with diabetes, lactating women, allergies to LY3841136 components, significant heart/liver/kidney diseases, severe allergies, or drug hypersensitivity cannot join.

What is being tested?

The study tests the safety and how the body processes LY3841136 in two parts over up to 14 weeks (Part A) and up to 28 weeks (Part B), involving multiple visits. It compares LY3841136 against a placebo in healthy and overweight individuals through blood tests.

What are the potential side effects?

While specific side effects are not listed here, common ones may include reactions at the injection site, nausea, headaches, fatigue or allergic reactions. The study aims to assess these by monitoring participants' tolerance.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose up to 14 weeks (part a) & 28 weeks (part b)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose up to 14 weeks (part a) & 28 weeks (part b)

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 14 weeks (part a) & 28 weeks (part b) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Secondary study objectives

PK: Maximum Observed Concentration (Cmax) of LY3841136

Pharmacodynamics (PD): Change From Baseline in Body Weight

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3841136

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3841136 (Part B)Experimental Treatment1 Intervention

Multiple ascending doses of LY3841136 administered SC.

Group II: LY3841136 (Part A)Experimental Treatment1 Intervention

Single ascending doses of LY3841136 administered subcutaneously (SC).

Group III: Placebo (Part A)Placebo Group1 Intervention

Placebo administered SC.

Group IV: Placebo (Part B)Placebo Group1 Intervention

Placebo administered SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3841136

2022

Completed Phase 1

~150

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity include glucagon-like peptide-1 (GLP-1) receptor agonists like liraglutide and semaglutide, which work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, leading to reduced appetite and increased satiety. Phentermine-topiramate combines an appetite suppressant with an anticonvulsant to promote weight loss. These mechanisms are crucial for obesity patients as they address the physiological aspects of hunger and satiety, making it easier to adhere to a reduced-calorie diet and achieve significant weight loss. The focus on safety and tolerability, as seen in the LY3841136 study, ensures that these treatments can be used long-term without adverse effects, which is essential for sustained weight management.

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