A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study of Once-Weekly Tirzepatide Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

18750

The main purpose of this study is to determine if combining tirzepatide with the mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 72 weeks and may include up to 19 visits.

2024-05-01

2025-12-01

2026-04-01

Not yet recruiting

Early phase I

360

Inclusion Criteria: * Have a body mass index (BMI) of ≥30 kilogram/square meter (kg/m2) and ≤40 kg/m2 * Willing to learn how to self-inject study intervention (visually impaired persons who are not able to perform the injections must have the assistance of a sighted individual trained to inject the study intervention; persons with physical limitations who are not able to perform the injections must have the assistance of an individual trained to inject the study intervention) * Male or female contraceptive use by participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Exclusion Criteria: * Have a history of diabetes mellitus, including Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM), history of ketoacidosis, or hyperosmolar state/coma * Have a self-reported change (increase or decrease) in body weight \>5 kilogram (kg) within 3 months prior to screening * Have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2 * 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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 360, 'type': 'ESTIMATED'}}

2024-04-30