RECRUITING

A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).

Official Title

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes

Quick Facts

Study Start:2025-05-15
Study Completion:2027-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06993792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
CONTACT
317-615-4559
clinical_inquiry_hub@lilly.com

Principal Investigator

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)
STUDY_DIRECTOR
Eli Lilly and Company

Study Locations (Sites)

Novak Clinical Research - Tucson - North La Cholla Boulevard
Tucson, Arizona, 85741
United States
Norcal Endocrinology & Internal Medicine
San Ramon, California, 94583
United States
Southern California Clinical Research
Santa Ana, California, 92701
United States
Care Access - Thousand Oaks
Thousand Oaks, California, 91360
United States
Accel Research Sites - DeLand Clinical Research Unit
DeLand, Florida, 32720
United States
Innovation Medical Research Center - Fort Lauderdale
Fort Lauderdale, Florida, 33316
United States
Encore Medical Research
Hollywood, Florida, 33024
United States
West Orange Endocrinology P.A.
Ocoee, Florida, 34761
United States
Care Access - Tampa
Tampa, Florida, 33625
United States
Care Access - Decatur
Decatur, Georgia, 30030
United States
Accel Research Sites - NeuroStudies Clinical Research Unit
Decatur, Georgia, 30033
United States
Javara - Privia Medical Group Georgia - Savannah
Savannah, Georgia, 31406
United States
North Georgia Clinical Research
Woodstock, Georgia, 30189
United States
Solaris Clinical Research
Meridian, Idaho, 83646
United States
Care Access - New Iberia
New Iberia, Louisiana, 70560
United States
Endocrine and Metabolic Consultants
Rockville, Maryland, 20852
United States
Javara - Privia Medical Group - Silver Spring
Silver Spring, Maryland, 20901
United States
Boeson Research MSO
Missoula, Montana, 59804
United States
Javara - Nevada Health Centers - Carson City
Carson City, Nevada, 89706
United States
The Machuca Foundation
Las Vegas, Nevada, 89101
United States
University of North Carolina Medical Center
Chapel Hill, North Carolina, 27514
United States
Javara - Tryon Medical Partners
Charlotte, North Carolina, 28210
United States
Care Access - Fayetteville
Fayetteville, North Carolina, 28314
United States
The Corvallis Clinic, P.C.
Corvallis, Oregon, 97330
United States
Clinical Research of Philadelphia
Philadelphia, Pennsylvania, 19114
United States
Frontier Clinical Research, LLC
Smithfield, Pennsylvania, 15478
United States
Velocity Clinical Research, Dallas
Dallas, Texas, 75230
United States
Biopharma Informatic, LLC
Houston, Texas, 77043
United States
Texas Valley Clinical Research (TVCR) - Mission
Mission, Texas, 78572
United States
Consano Clinical Research, LLC
Shavano Park, Texas, 78231
United States

Collaborators and Investigators

Sponsor: Eli Lilly and Company

  • 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), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-15
Study Completion Date2027-08

Study Record Updates

Study Start Date2025-05-15
Study Completion Date2027-08

Terms related to this study

Additional Relevant MeSH Terms

  • Obesity
  • Overweight
  • Type 2 Diabetes