A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity

Obesity Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06373146
• Other study ID #: 18750
• Secondary ID: I8F-MC-GPIV
• Status: Recruiting
• Phase: Phase 2
• Start date: April 24, 2024
• Est. completion date: April 2026

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 360
• Est. completion date: April 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Tirzepatide
Administered SC
• Mibavademab
Administered SC
• Tirzepatide-Placebo
Administered SC
• Mibavademab-Placebo
Administered SC

Locations

Country	Name	City	State
Mexico	Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos	Chihuahua
Mexico	Centro de Investigación Clínica y Medicina Traslacional (CIMeT)	Guadalajara	Jalisco
Mexico	Medical Care and Research SA de CV	Merida	Yucatán
Mexico	Centro de Investigacion en Artritis y Osteoporosis SC	Mexicali	Baja California
Mexico	Clínicos Asociados BOCM	Mexico City	Distrito Federal
Mexico	Hospital Universitario "Dr. Jose Eleuterio Gonzalez"	Monterrey	Nuevo León
Mexico	Unidad biomedica avanzada monterrey	Monterrey	Nuevo León
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	CenExel-HRI	Berlin	New Jersey
United States	CTI-CRC	Cincinnati	Ohio
United States	South Texas Clinical Research	Corpus Christi	Texas
United States	Dallas Diabetes Research Center	Dallas	Texas
United States	Lillestol Research	Fargo	North Dakota
United States	Velocity Clinical Research, Gardena	Gardena	California
United States	Juno Research	Houston	Texas
United States	Irvine Clinical Research	Irvine	California
United States	National Research Institute - Wilshire	Los Angeles	California
United States	Tandem Clinical Research	Marrero	Louisiana
United States	Solaris Clinical Research	Meridian	Idaho
United States	Velocity Clinical Research - New Orleans	New Orleans	Louisiana
United States	Velocity Clinical Research, North Hollywood	North Hollywood	California
United States	Velocity Clinical Research, Panorama City	Panorama City	California
United States	Velocity Clinical Research, Santa Ana	Santa Ana	California
United States	Diablo Clinical Research, Inc.	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

United States,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean Percent Change from Baseline in Body Weight		Baseline, Week 48
Secondary	Mean Change from Baseline for Percent Change and Absolute Change in Body Weight (kg)		Baseline, Week 24
Secondary	Mean Absolute Change from Baseline for Body Weight (kg)		Baseline, Week 48
Secondary	Percentage of Participants Who Achieve =5% Body Weight Reduction		Baseline to Week 48
Secondary	Percentage of Participants Who Achieve =10% Body Weight Reduction		Baseline to Week 48
Secondary	Percentage of Participants Who Achieve =15% Body Weight Reduction		Baseline to Week 48
Secondary	Percentage of Participants Who Achieve =20 Body Weight Reduction		Baseline to Week 48
Secondary	Mean Percent Change from Randomization 2 for Body Weight		Week 24, Week 48
Secondary	Mean Change from Randomization 2 for Body Weight (kg)		Week 24, Week 48
Secondary	Mean Absolute Change from Randomization 2 for Body Weight (kg)		Week 24, Week 48
Secondary	Change from Baseline to Week 24 in CoEQ Scores		Baseline, Week 24
Secondary	Change from Baseline to Week 24 in CoEQ Scores		Baseline, Week 48
Secondary	Change from Baseline in FCQ-T-r Scores		Baseline, Week 24
Secondary	Change from Baseline in FCQ-T-r Scores		Baseline, Week 48

External Links

•   A Study of Tirzepatide (LY3298176) Plus Mibavademab Compared With Tirzepatide Alone in Adult Participants With Obesity