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LY3841136 + Tirzepatide for Obesity with Type 2 Diabetes
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
Must not have
W8M-MC-LAA2: Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliters per minute (mL/min)/1.73 m2
W8M-MC-LAA2: Have a history of acute or chronic pancreatitis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial aims to study the safety and effectiveness of a drug called LY3841136 for managing weight in individuals with Type 2 Diabetes. The study will also look at how combining LY3841136
Who is the study for?
This trial is for adults with obesity or overweight who also have Type 2 Diabetes. Participants will be involved in the study for about 64 weeks to test weight management treatments.
What is being tested?
The study tests LY3841136 and Tirzepatide, alone or combined, for managing weight. Some participants may receive a placebo instead to compare effects.
What are the potential side effects?
Possible side effects of LY3841136 and Tirzepatide could include gastrointestinal issues like nausea or diarrhea, potential low blood sugar levels, fatigue, and injection site reactions.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My kidney function is reduced, with an eGFR below 45 mL/min.
Select...
I have a history of pancreatitis.
Select...
I have a history of slow heartbeats.
Select...
I have had symptoms of gallbladder problems in the last 2 years.
Select...
My high blood pressure is not well-controlled.
Select...
I have type 1 diabetes or a history of severe diabetes complications.
Select...
I have liver disease symptoms not caused by nonalcoholic fatty liver disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Trial Design
10Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: LY3841136 Dose 3 + Tirzepatide Dose 3Experimental Treatment2 Interventions
Participants will receive LY3841136 SC and Tirzepatide SC
Group II: LY3841136 Dose 3Experimental Treatment1 Intervention
Participants will receive LY3841136 SC
Group III: LY3841136 Dose 2 + Tirzepatide Dose 3Experimental Treatment2 Interventions
Participants will receive LY3841136 SC and Tirzepatide SC
Group IV: LY3841136 Dose 2 + Tirzepatide Dose 2Experimental Treatment2 Interventions
Participants will receive LY3841136 SC and Tirzepatide SC
Group V: LY3841136 Dose 2 + Tirzepatide Dose 1Experimental Treatment2 Interventions
Participants will receive LY3841136 SC and Tirzepatide SC
Group VI: LY3841136 Dose 2Experimental Treatment1 Intervention
Participants will receive LY3841136 SC
Group VII: LY3841136 Dose 1 + Tirzepatide Dose 1Experimental Treatment2 Interventions
Participants will receive LY3841136 SC and Tirzepatide SC
Group VIII: LY3841136 Dose 1Experimental Treatment1 Intervention
Participants will receive LY3841136 subcutaneously (SC)
Group IX: Tirzepatide Dose 3Active Control1 Intervention
Participants will receive Tirzepatide SC
Group X: PlaceboPlacebo Group1 Intervention
Participants will receive placebo administered SC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3841136
2022
Completed Phase 1
~150
Tirzepatide
2019
Completed Phase 3
~7520
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,034 Total Patients Enrolled
69 Trials studying Obesity
46,737 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,491 Total Patients Enrolled
52 Trials studying Obesity
25,542 Patients Enrolled for Obesity