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LY3841136 + Tirzepatide for Obesity

Phase 1

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, week 42

Awards & highlights

Study Summary

This trial will test how safe and well-tolerated a new drug, LY3841136, is when given with another drug, tirzepatitide, to overweight and obese patients.

Who is the study for?

This clinical trial is for overweight and obese individuals who are interested in testing a new treatment. Specific eligibility criteria to join the study have not been provided, but typically participants must meet certain health conditions.Check my eligibility

What is being tested?

The trial is evaluating the safety and tolerability of a drug called LY3841136 when used with another medication named tirzepatide. The study will track participant responses over a period of up to 42 weeks.See study design

What are the potential side effects?

While specific side effects are not listed, common reactions to weight loss drugs can include gastrointestinal issues like nausea or diarrhea, headaches, increased heart rate, and potential allergic reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 42

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 42

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 42 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants With One or More Treatment Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration

Secondary outcome measures

Percent Change from Baseline in Body Weight

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

Pharmacokinetics (PK): Maximum plasma concentration (Cmax) of LY3841136

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3841136 + TirzepatideExperimental Treatment2 Interventions

LY3841136 administered subcutaneously (SC) in combination with tirzepatide given SC.

Group II: Placebo + TirzepatidePlacebo Group2 Interventions

Placebo administered SC in combination with tirzepatide given SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tirzepatide

2019

Completed Phase 3

~5780

LY3841136

2022

Completed Phase 1

~150

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor

2,622 Previous Clinical Trials

3,216,695 Total Patients Enrolled

55 Trials studying Obesity

51,139 Patients Enrolled for Obesity

Study DirectorEli Lilly and Company

1,349 Previous Clinical Trials

415,818 Total Patients Enrolled

38 Trials studying Obesity

30,858 Patients Enrolled for Obesity

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria are used to determine eligibility for participation in this medical study?

"To be eligible for participation, individuals must meet criteria including being between 18 and 65 years old and having a diagnosis of obesity. This research study aims to enroll approximately 80 participants."

Answered by AI

Is the clinical trial open to individuals younger than 80 years old?

"As per the trial's eligibility criteria, individuals aged 18 to 65 are eligible for enrollment."

Answered by AI

Is the recruitment phase still ongoing for participants in this medical study?

"The current status on clinicaltrials.gov indicates that patient enrollment is not ongoing for this particular study. The trial was first listed on 4/3/2024 and last updated on 3/28/2024. It's worth noting that while this specific trial is not actively enrolling, there are currently 1216 other trials seeking participants."

Answered by AI

Has the combination of LY3841136 and Tirzepatide been granted approval by the FDA?

"The safety rating for LY3841136 + Tirzepatide is assigned a score of 1 by our team due to its Phase 1 trial status, indicating limited evidence supporting both safety and efficacy."

Answered by AI