A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
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
2 other identifiers
interventional
392
1 country
17
Brief Summary
The main purpose of this study is to determine if combining tirzepatide with mibavademab will result in more weight loss in adult participants than tirzepatide alone. The study will last about 74 weeks and may include up to 19 visits.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Apr 2024
Typical duration for phase_2 obesity
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2024
CompletedFirst Posted
Study publicly available on registry
April 18, 2024
CompletedStudy Start
First participant enrolled
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 2, 2026
CompletedMay 6, 2026
May 1, 2026
1.6 years
April 16, 2024
May 4, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Percent Change from Baseline in Body Weight
Baseline, Week 48
Secondary Outcomes (13)
Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg)
Baseline, Week 24
Mean Absolute Change from Baseline for Body Weight (kg)
Baseline, Week 48
Percentage of Participants Who Achieve ≥5% Body Weight Reduction
Baseline to Week 48
Percentage of Participants Who Achieve ≥10% Body Weight Reduction
Baseline to Week 48
Percentage of Participants Who Achieve ≥15% Body Weight Reduction
Baseline to Week 48
- +8 more secondary outcomes
Study Arms (8)
Tirzepatide (TZP) + Mibavademab (MIBA) [Group A]
EXPERIMENTALParticipants 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.
TZP + Mibavademab-placebo (MIBA-PBO) [Group B]
EXPERIMENTALParticipants 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.
TZP + MIBA then Tirzepatide-placebo (TZP-PBO) + MIBA [Group C]
EXPERIMENTALParticipants will receive TZP SC and MIBA SC for 24 weeks followed by TZP-PBO SC and MIBA SC for 24 weeks.
TZP + MIBA [Group D]
EXPERIMENTALParticipants will receive TZP SC + MIBA SC for 48 weeks.
TZP + MIBA-PBO [Group E]
EXPERIMENTALParticipants will receive TZP SC + MIBA-PBO SC for 48 weeks.
TZP + MIBA-PBO then TZP-PBO + MIBA [Group F]
EXPERIMENTALParticipants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA SC for 24 weeks.
TZP + MIBA-PBO then TZP + MIBA [Group G]
EXPERIMENTALParticipants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP SC + MIBA SC for 24 weeks.
TZP + MIBA-PBO then TZP-PBO + MIBA-PBO [Group H]
EXPERIMENTALParticipants will receive TZP SC + MIBA-PBO SC for 24 weeks followed by TZP-PBO SC + MIBA-PBO SC for 24 weeks.
Interventions
Administered SC
Administered SC
Administered SC
Administered SC
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Regeneron Pharmaceuticalscollaborator
- Eli Lilly and Companylead
Study Sites (17)
Velocity Clinical Research, Gardena
Gardena, California, 90247, United States
Irvine Clinical Research
Irvine, California, 92614, United States
Velocity Clinical Research, Los Angeles
Los Angeles, California, 90017, United States
Velocity Clinical Research, North Hollywood
North Hollywood, California, 91606, United States
Velocity Clinical Research, Santa Ana
Santa Ana, California, 92704, United States
Velocity Clinical Research, Panorama City
Van Nuys, California, 91405, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Solaris Clinical Research
Meridian, Idaho, 83646, United States
Tandem Clinical Research
Marrero, Louisiana, 70072, United States
Velocity Clinical Research - New Orleans
New Orleans, Louisiana, 70119, United States
Hassman Research Institute Marlton Site
Marlton, New Jersey, 08053, United States
Lillestol Research
Fargo, North Dakota, 58104, United States
CTI Clinical Research Center
Cincinnati, Ohio, 45212, United States
South Texas Clinical Research
Corpus Christi, Texas, 78404, United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230, United States
Juno Research
Houston, Texas, 77040, United States
Northwest Clinical Research Center
Bellevue, Washington, 98007, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2024
First Posted
April 18, 2024
Study Start
April 24, 2024
Primary Completion
December 15, 2025
Study Completion
April 2, 2026
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.