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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06373146
Other study ID # 18750
Secondary ID I8F-MC-GPIV
Status Recruiting
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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