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Monoclonal Antibodies
Bimagrumab + Tirzepatide 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
Must not have
Prior or planned surgical treatment for obesity
Use of metformin or any other glucose-lowering medications
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Summary
This trial aims to test the effectiveness and safety of two medications, Bimagrumab and Tirzepatide, either alone or combined, in adults who are overweight or obese and have at least
Who is the study for?
This trial is for adults with obesity or overweight who also have at least one weight-related health issue but do not have Type 2 Diabetes. The study will last approximately 54 weeks.
What is being tested?
The effectiveness and safety of two medications, Bimagrumab and Tirzepatide, are being tested. They can be given alone or together to see how well they help with weight management in obese or overweight individuals.
What are the potential side effects?
Possible side effects of Bimagrumab may include muscle spasms, changes in blood tests related to the muscles, and gastrointestinal issues. Tirzepatide might cause nausea, diarrhea, decreased appetite, vomiting, constipation or increased heart rate.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had or am planning to have surgery for weight loss.
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I am taking metformin or other medications to lower my blood sugar.
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I have diabetes, but not just gestational diabetes, and have had ketoacidosis or hyperosmolar coma.
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My blood pressure is not well controlled.
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I have a history of frequent or ongoing fast heart rhythms.
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I have a history of slow heart rhythms, not including normal slow heartbeats.
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I have a condition that affects how my stomach and intestines absorb food.
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I have severe heart failure.
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I have had symptoms of gallbladder problems in the last 2 years.
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I show signs or symptoms of liver disease.
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I have had pancreatitis before.
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My kidney function is severely reduced.
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
7Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Bimagrumab Dose 2 + Tirzepatide Dose 2Experimental Treatment2 Interventions
Participants will receive Bimagrumab SC and Tirzepatide SC
Group II: Bimagrumab Dose 2Experimental Treatment1 Intervention
Participants will receive Bimagrumab SC
Group III: Bimagrumab Dose 1 + Tirzepatide Dose 2Experimental Treatment2 Interventions
Participants will receive Bimagrumab SC and Tirzepatide SC
Group IV: Bimagrumab Dose 1 + Tirzepatide Dose 1Experimental Treatment2 Interventions
Participants will receive Bimagrumab SC and Tirzepatide SC
Group V: Tirzepatide Dose 1Active Control1 Intervention
Participants will receive Tirzepatide subcutaneously (SC)
Group VI: Tirzepatide Dose 2Active Control1 Intervention
Participants will receive Tirzepatide SC
Group VII: PlaceboPlacebo Group1 Intervention
Participants will receive Placebo SC
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7520
Bimagrumab
2015
Completed Phase 3
~220
Find a Location
Who is running the clinical trial?
Eli Lilly and CompanyLead Sponsor
2,680 Previous Clinical Trials
3,466,244 Total Patients Enrolled
69 Trials studying Obesity
46,947 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,701 Total Patients Enrolled
52 Trials studying Obesity
25,752 Patients Enrolled for Obesity