What side effects are associated with this type of intervention?

Common treatments for obesity include glucagon-like peptide-1 (GLP-1) receptor agonists, phentermine-topiramate combinations, and tirzepatide. GLP-1 receptor agonists, such as ExQW, are generally well tolerated but can cause gastrointestinal issues like nausea and vomiting. Phentermine-topiramate combinations can lead to dry mouth, increased heart rate, and insomnia. Tirzepatide, another GLP-1 receptor agonist, primarily causes mild to moderate gastrointestinal side effects, including nausea and diarrhea, especially during dose escalation. These treatments are effective for weight loss but require monitoring for these potential side effects.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including glucagon-like peptide-1 (GLP-1) receptor agonists such as liraglutide and semaglutide. These medications have shown efficacy in weight management by promoting satiety and reducing appetite. Additionally, combination therapies like phentermine-topiramate have been approved, demonstrating significant weight loss in clinical trials. These treatments are part of a broader strategy to manage obesity, similar to the investigational drug LY3305677 being studied for its weight management efficacy.

What other types of research exist?

Promising alternatives to LY3305677 for weight management in obesity patients include: 1) Metformin, which is well-tolerated and effective for weight loss, especially in patients with severe mental illness. 2) Liraglutide, a GLP-1 agonist, which has shown benefits in weight loss and cardiovascular outcomes. 3) Combination treatments like olanzapine/samidorphan for patients on antipsychotic medications. 4) New agents in phase II and III trials, such as those reviewed in recent studies, though specific names are not provided in the context.

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LY3305677 for Obesity

Phase 2

Recruiting

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 baseline to week 56

Summary

This trial is testing a new medication called LY3305677 to help adults who are obese or overweight manage their weight. The study will last over a year. Researchers want to see if this medication helps people lose weight and if it is safe to use.

Who is the study for?

This trial is for adults with obesity or overweight, having a BMI of at least 27 kg/m² and one weight-related health issue. Participants must have maintained stable body weight (less than 5% change) in the past three months and agree to follow reproductive safety measures.

What is being tested?

The study tests LY3305677 against a placebo over approximately 62 weeks to see if it's effective and safe for managing weight in obese or overweight adults. It follows a master protocol, meaning it's part of larger research efforts.

What are the potential side effects?

Specific side effects are not listed here, but typically trials like this monitor for any negative reactions ranging from mild discomforts such as nausea or headaches to more serious issues related to metabolism or heart function.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 56 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Absolute Change from Baseline in Liver Fat Content by MRI-PDFF

Absolute Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF)

Change from Baseline in BMI

+9 more

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3305677 Dose 3Experimental Treatment1 Intervention

Participants will receive LY3305677 SC.

Group II: LY3305677 Dose 2Experimental Treatment1 Intervention

Participants will receive LY3305677 SC.

Group III: LY3305677 Dose 1Experimental Treatment1 Intervention

Participants will receive LY3305677 subcutaneously (SC).

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive LY3305677 matching placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3305677

2017

Completed Phase 1

~180

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 often involve pharmacological agents that target appetite regulation and metabolic processes. Glucagon-like peptide-1 (GLP-1) receptor agonists, such as semaglutide and liraglutide, work by enhancing insulin secretion, inhibiting glucagon release, and slowing gastric emptying, which collectively reduce appetite and promote satiety. Another combination therapy, phentermine-topiramate, acts by suppressing appetite through central nervous system stimulation and enhancing satiety. These mechanisms are crucial for obesity patients as they directly address the physiological drivers of overeating and weight gain, thereby aiding in significant and sustained weight loss. Understanding these mechanisms helps in tailoring treatments to individual patient needs, improving adherence, and optimizing outcomes.

[Action mechanisms of anti-obesity drugs].