Clinical trial NCT06373146: A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity
Official title: 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Obesity
Keywords: Glucagon-like peptide-1 (GLP-1)
Leptin
Incretin
Weight maintenance
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2024-04-18
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Percent Change from Baseline in Body Weight
timeFrame: Baseline, Week 48
Secondary outcomes:
measure: Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg)
timeFrame: Baseline, Week 24
measure: Mean Absolute Change from Baseline for Body Weight (kg)
timeFrame: Baseline, Week 48
measure: Percentage of Participants Who Achieve ≥5% Body Weight Reduction
timeFrame: Baseline to Week 48
measure: Percentage of Participants Who Achieve ≥10% Body Weight Reduction
timeFrame: Baseline to Week 48
measure: Percentage of Participants Who Achieve ≥15% Body Weight Reduction
timeFrame: Baseline to Week 48
measure: Percentage of Participants Who Achieve ≥20 Body Weight Reduction
timeFrame: Baseline to Week 48
measure: Mean Percent Change from Randomization 2 for Body Weight
timeFrame: Week 24, Week 48
measure: Mean Change from Randomization 2 for Body Weight (kg)
timeFrame: Week 24, Week 48
measure: Mean Absolute Change from Randomization 2 for Body Weight (kg)
timeFrame: Week 24, Week 48
measure: Change from Baseline to Week 24 in CoEQ Scores
timeFrame: Baseline, Week 24
measure: Change from Baseline to Week 48 in CoEQ Scores
timeFrame: Baseline, Week 48
measure: Change from Baseline in FCQ-T-r Scores
timeFrame: Baseline, Week 24
measure: Change from Baseline in FCQ-T-r Scores
timeFrame: Baseline, Week 48
Other outcomes:
Locations:
city: Gardena
country: United States
facility: Velocity Clinical Research, Gardena
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research
state: California
city: Los Angeles
country: United States
facility: Velocity Clinical Research, Westlake
state: California
city: North Hollywood
country: United States
facility: Velocity Clinical Research, North Hollywood
state: California
city: Santa Ana
country: United States
facility: Velocity Clinical Research, Santa Ana
state: California
city: Van Nuys
country: United States
facility: Velocity Clinical Research, Panorama City
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Meridian
country: United States
facility: Solaris Clinical Research
state: Idaho
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: New Orleans
country: United States
facility: Velocity Clinical Research - New Orleans
state: Louisiana
city: Marlton
country: United States
facility: Hassman Research Institute Marlton Site
state: New Jersey
city: Fargo
country: United States
facility: Lillestol Research
state: North Dakota
city: Cincinnati
country: United States
facility: CTI Clinical Research Center
state: Ohio
city: Corpus Christi
country: United States
facility: South Texas Clinical Research
state: Texas
city: Dallas
country: United States
facility: Velocity Clinical Research, Dallas
state: Texas
city: Houston
country: United States
facility: Juno Research
state: Texas
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: