What side effects are associated with this type of intervention?

Common treatments for obesity, such as GLP-1 receptor agonists (e.g., liraglutide, semaglutide), phentermine-topiramate, and orlistat, have various side effects. GLP-1 receptor agonists often cause gastrointestinal issues like nausea, vomiting, and diarrhea. Phentermine-topiramate can lead to dry mouth, constipation, insomnia, and potential cardiovascular effects. Orlistat is associated with gastrointestinal side effects, including oily stools, flatulence, and frequent bowel movements. These side effects should be discussed with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity that work through various mechanisms such as metabolic modulation, appetite suppression, and fat absorption inhibition. Notable examples include liraglutide, a GLP-1 receptor agonist that enhances satiety and reduces appetite, and phentermine-topiramate, a combination that suppresses appetite and increases energy expenditure. Orlistat, another approved drug, works by inhibiting fat absorption in the intestines. These treatments have shown efficacy in weight management and are relevant to the ongoing study of LY3841136, which aims to explore similar mechanisms for weight control in individuals with obesity or overweight.

What other types of research exist?

Promising alternatives to LY3841136 for weight management in obesity patients include: 1) Phentermine-topiramate combination, which has shown significant weight loss in clinical trials. 2) GLP-1 receptor agonists like S 23521, which have demonstrated efficacy in reducing food intake and body weight in animal studies. 3) Anamorelin, a ghrelin mimetic, which has potential for increasing energy intake and managing cachexia, though its application in obesity needs further exploration.

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LY3841136 for Obesity

Q: What is the mechanism of action of this treatment?

Common treatments for obesity work through mechanisms such as metabolic modulation, appetite suppression, and fat absorption inhibition. For example, GLP-1 receptor agonists enhance insulin secretion, slow gastric emptying, and reduce appetite, which helps in weight management. Phentermine-topiramate combines appetite suppression with increased energy expenditure, while fat absorption inhibitors like orlistat prevent the digestion and absorption of dietary fats, reducing caloric intake. These mechanisms are crucial as they address the underlying physiological and behavioral factors contributing to obesity, helping patients achieve and maintain weight loss.

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

BMI ≥27 kg/m² and <30 kg/m² with at least one of the following weight-related comorbidities: hypertension on blood pressure (BP)-lowering medication, dyslipidemia on lipid-lowering medication, cardiovascular (CV) disease (e.g., ischemic CV disease, New York Heart Association (NYHA) Functional Classification Class 1 or II Heart Failure), obstructive sleep apnea

Be older than 18 years old

Must not have

Signs and symptoms of any liver disease other than nonalcoholic fatty liver disease

Lifetime history of suicide attempts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Summary

This trial is testing a new medication called LY3841136 to help adults who are overweight or obese manage their weight. The study aims to see if this medication is safe and effective over several months.

Who is the study for?

This trial is for adults who are overweight or have obesity. Specific details about eligibility criteria were not provided, so interested individuals should consult the study team for more information.

What is being tested?

The study is testing a new medication called LY3841136 against a placebo to see if it helps with weight management in obese or overweight adults. The trial will go on for about 64 weeks and may require participants to attend up to 13 visits.

What are the potential side effects?

Potential side effects of LY3841136 are not listed here, but typically, weight management drugs can cause gastrointestinal issues, headaches, increased heart rate, and other symptoms. Participants should ask the research team for detailed side effect information.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My BMI is between 27 and 30, and I have a weight-related health issue.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have liver disease symptoms not caused by fatty liver.

Select...

I have attempted suicide in the past.

Select...

I have been diagnosed with diabetes, but not just during pregnancy.

Select...

I have had pancreatitis before.

Select...

I have severe heart failure.

Select...

I have type 1 diabetes or a history of severe diabetes complications.

Select...

My high blood pressure is not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3841136 Dose 6Experimental Treatment1 Intervention

Participants will receive LY3841136 SC

Group II: LY3841136 Dose 5Experimental Treatment1 Intervention

Participants will receive LY3841136 SC

Group III: LY3841136 Dose 4Experimental Treatment1 Intervention

Participants will receive LY3841136 SC.

Group IV: LY3841136 Dose 3Experimental Treatment1 Intervention

Participants will receive LY3841136 SC

Group V: LY3841136 Dose 2Experimental Treatment1 Intervention

Participants will receive LY3841136 SC

Group VI: LY3841136 Dose 1Experimental Treatment1 Intervention

Participants will receive LY3841136 subcutaneously (SC)

Group VII: PlaceboPlacebo Group1 Intervention

Participants will receive LY3841136 matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3841136

2022

Completed Phase 1

~150

0 / 8Eligibility criteria met

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 work through mechanisms such as metabolic modulation, appetite suppression, and fat absorption inhibition. For example, GLP-1 receptor agonists enhance insulin secretion, slow gastric emptying, and reduce appetite, which helps in weight management. Phentermine-topiramate combines appetite suppression with increased energy expenditure, while fat absorption inhibitors like orlistat prevent the digestion and absorption of dietary fats, reducing caloric intake. These mechanisms are crucial as they address the underlying physiological and behavioral factors contributing to obesity, helping patients achieve and maintain weight loss.

The complicated clinical course in a case of atypical lipodystrophy after development of neutralizing antibody to metreleptin: treatment with setmelanotide.