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Monoclonal Antibodies

Tirzepatide + Mibavademab 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
Have acute or chronic hepatitis
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

"This trial will investigate if combining tirzepatide with mibavademab leads to more weight loss in adults compared to using tirzepatide alone. The study will last approximately

Who is the study for?
This trial is for adults with obesity who are looking to lose weight. Participants should be committed to the study duration of about 72 weeks and up to 19 visits. Specific eligibility criteria details were not provided, so interested individuals should inquire further.
What is being tested?
The study is testing whether a combination of two drugs, Tirzepatide and Mibavademab, leads to more weight loss compared to just Tirzepatide alone in obese adults over approximately a year and a half.
What are the potential side effects?
Potential side effects were not detailed; however, as with any medication, there could be risks such as allergic reactions or gastrointestinal issues. Participants will need to discuss possible side effects with the research team.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have hepatitis.
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I have been in remission for less than 5 years or have an active cancer.
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I have diabetes (Type 1 or Type 2) or have had severe diabetes complications.
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I or my family have a history of thyroid cancer or MEN syndrome type 2.

Timeline

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

8Treatment groups
Experimental Treatment
Group I: Tirzepatide (TZP) + Mibavademab (MIBA) [Group A]Experimental Treatment2 Interventions
Participants will receive TZP subcutaneously (SC) and MIBA for 24 weeks. Participants in Group A will be randomized (Randomization 2) to groups C and D at week 24.
Group II: TZP + Mibavademab-placebo (MIBA-PBO) [Group B]Experimental Treatment2 Interventions
Participants will receive TZP SC and MIBA-PBO SC for 24 weeks. Participants in Group B will be randomized (Randomization 2) to Groups E, F, G, and H at week 24.
Group III: TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H]Experimental Treatment3 Interventions
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks.
Group IV: TZP + MIBA-PBO then TZP-PBO + MIBA [Group F]Experimental Treatment4 Interventions
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks.
Group V: TZP + MIBA-PBO then TZP + MIBA [Group G]Experimental Treatment3 Interventions
Participants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks.
Group VI: TZP + MIBA-PBO [Group E]Experimental Treatment2 Interventions
Participants will receive TZP SC + MIBA-PBO SC for 48 weeks.
Group VII: TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C]Experimental Treatment3 Interventions
Participants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks.
Group VIII: TZP + MIBA [Group D]Experimental Treatment2 Interventions
Participants will receive TZP SC + MIBA SC for 48 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
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
3,466,024 Total Patients Enrolled
69 Trials studying Obesity
46,727 Patients Enrolled for Obesity
Regeneron PharmaceuticalsIndustry Sponsor
671 Previous Clinical Trials
385,464 Total Patients Enrolled
2 Trials studying Obesity
1,053 Patients Enrolled for Obesity
Study DirectorEli Lilly and Company
1,391 Previous Clinical Trials
428,481 Total Patients Enrolled
52 Trials studying Obesity
25,532 Patients Enrolled for Obesity
~208 spots leftby Dec 2025
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