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

Phase 3
Recruiting
Conditions
Obesity
Overweight
Type 2 Diabetes
Interventions
Drug: Placebo
Registration Number
NCT06993792
Lead Sponsor
Eli Lilly and Company
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
1200
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Orforglipron Dose 1 (Study GZP1)OrforglipronParticipants will receive orforglipron orally
Orforglipron Dose 2 (Study GZP1)OrforglipronParticipants will receive orforglipron orally
Orforglipron Dose 3 (Study GZP1)OrforglipronParticipants will receive orforglipron orally
Orforglipron Dose 4 (Study GZP1)OrforglipronParticipants will receive orforglipron orally
Placebo (Study GZP1)PlaceboParticipants will receive placebo orally
Orforglipron Dose 1 (Study GZP2)OrforglipronParticipants will receive orforglipron orally
Orforglipron Dose 2 (Study GZP2)OrforglipronParticipants will receive orforglipron orally
Orforglipron Dose 3 (Study GZP2)OrforglipronParticipants will receive orforglipron orally
Orforglipron Dose 4 (Study GZP2)OrforglipronParticipants will receive orforglipron orally
Placebo (Study GZP2)PlaceboParticipants will receive placebo orally
Primary Outcome Measures
NameTimeMethod
Number of Participants Allocated to Each StudyBaseline to Week 4
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (89)

Novak Clinical Research - Tucson - North La Cholla Boulevard

🇺🇸

Tucson, Arizona, United States

Norcal Endocrinology & Internal Medicine

🇺🇸

San Ramon, California, United States

Southern California Clinical Research

🇺🇸

Santa Ana, California, United States

Care Access - Thousand Oaks

🇺🇸

Thousand Oaks, California, United States

Accel Research Sites - DeLand Clinical Research Unit

🇺🇸

DeLand, Florida, United States

Innovation Medical Research Center - Fort Lauderdale

🇺🇸

Fort Lauderdale, Florida, United States

Encore Medical Research

🇺🇸

Hollywood, Florida, United States

West Orange Endocrinology P.A.

🇺🇸

Ocoee, Florida, United States

Care Access - Tampa

🇺🇸

Tampa, Florida, United States

Accel Research Sites - NeuroStudies Clinical Research Unit

🇺🇸

Decatur, Georgia, United States

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Novak Clinical Research - Tucson - North La Cholla Boulevard
🇺🇸Tucson, Arizona, United States
Thili Kulatilake
Principal Investigator
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