CClinicalTrials.gg
Active, not recruitingNCT06972459Updated Jul 29, 2026

A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity

A Phase 3 interventional study of Orforglipron and Placebo in Obesity and Overweight, sponsored by Eli Lilly and Company. Active, not recruiting at 80 sites in 7 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-29.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
800
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The main purpose of this study is to see how orforglipron, compared with placebo, helps reduce body weight in participants with obesity or with overweight and at least one other related health condition (excluding type 2 diabetes). This trial is part of the master protocol study J2A-MC-GZPO (NCT06993792).

Participation in the study will last about 18 months.

02

Conditions studied

  • Obesity
  • Overweight
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's planned enrollment of 800 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:

    • hypertension
    • dyslipidemia
    • obstructive sleep apnea, or
    • cardiovascular disease
  • Have a history of at least one unsuccessful dietary effort to lose body weight

Exclusion criteria

Exclusion Criteria:

  • Have type 1 diabetes, type 2 diabetes, or any other types of diabetes
  • Have an unstable body weight within 90 days prior to screening
  • Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening
  • Have acute or chronic hepatitis or pancreatitis
  • Are taking other medications or alternative remedies to manage weight loss
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
800 participants (estimated)

Study arms

  • Experimental
    Orforglipron Dose 1

    Participants will receive orforglipron orally

    Drug: Orforglipron

  • Experimental
    Orforglipron Dose 2

    Participants will receive orforglipron orally

    Drug: Orforglipron

  • Experimental
    Orforglipron Dose 3

    Participants will receive orforglipron orally

    Drug: Orforglipron

  • Experimental
    Orforglipron Dose 4

    Participants will receive orforglipron orally

    Drug: Orforglipron

  • Placebo comparator
    Placebo

    Participants will receive placebo orally

    Drug: Placebo

Interventions

  • DrugOrforglipron

    Administered orally

    Also known as: LY3502970

  • DrugPlacebo

    Administered orally

06

What researchers measure

Primary outcomes

  1. Percent Change from Baseline in Body Weight

    Time frame: Baseline, Week 72

Secondary outcomes

  1. Percentage of Participants Achieving Weight Reduction of ≥5%

    Time frame: Baseline up to 72 weeks

  2. Change from Baseline in Waist Circumference

    Time frame: Baseline up to 72 weeks

  3. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline, Week 72

  4. Change from Baseline in Systolic Blood Pressure (SBP)

    Time frame: Baseline up to 72 weeks

  5. Percent Change from Baseline in Triglycerides

    Time frame: Baseline up to 72 weeks

  6. Change from Baseline in Hemoglobin A1c (HbA1c)

    Time frame: Baseline up to 72 weeks

  7. Change from Baseline in Fasting Glucose

    Time frame: Baseline up to 72 weeks

  8. Change from Baseline in EQ-5D-5L

    Time frame: Baseline, Week 72

  9. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron

    Time frame: Predose through Week 48

07

Study locations

80 sites
  • Clinical Research Institute of Arizona (CRI) - Sun City West
    Sun City West, Arizona 85375, United States
  • 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
  • Indago Research & Health Center, Inc
    Hialeah, Florida 33012, 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
  • Conquest Research
    Winter Park, Florida 32789, United States
  • Accel Research Sites - NeuroStudies Clinical Research Unit
    Decatur, Georgia 30030, United States
  • Care Access - Decatur
    Decatur, Georgia 30030, 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
  • Great Lakes Research Group, Inc.
    Bay City, Michigan 48706, 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
  • Activian Clinical Research
    Kingwood, Texas 77339, United States
  • Texas Valley Clinical Research (TVCR) - Mission
    Mission, Texas 78572, United States
  • Consano Clinical Research, LLC
    Shavano Park, Texas 78231, United States
  • CARE - Centro de Alergia y Enfermedades Respiratorias
    Buenos Aires, 1414, Argentina
  • CIPREC
    Buenos Aires, C1119ACN, Argentina
  • Centro Médico Viamonte
    Buenos Aires, C1120AAC, Argentina
  • Instituto Centenario
    CABA, 1204, Argentina
  • Instituto Médico Catamarca IMEC
    Rosario, 2000, Argentina
  • Centro de Diagnóstico y Rehabilitación (CEDIR)
    Santa Fe, 3000, Argentina
  • Xuanwu Hospital Capital Medical University
    Beijing, 100053, China
  • Peking University Third Hospital
    Beijing, 100091, China
  • Sichuan Provincial People's Hospital
    Chengdu, 610072, China
  • The Second Affiliated Hospital Chongqing Medical University
    Chongqing, 400010, China
  • Zhujiang Hospital
    Guangzhou, 510280, China
  • The Fourth Affiliated Hospital of Harbin Medical University
    Harbin, 150001, China
  • The Second People's Hospital of Hefei
    Hefei, 230011, China
  • Jinan Central Hospital
    Jinan, 250013, China
  • The First Affiliated Hospital of Henan University of Science &Technology
    Luoyang Shi, 471003, China
  • Zhongda Hospital Southeast University
    Nanjing, 210009, China
  • The Second Affiliated Hospital of Nanjing Medical University
    Nanjing, 210011, China
  • The Second Hospital of Tianjin Medical University
    Tianjin, 300211, China
  • MUDr. Alena Vachova
    České Budějovice, 37011, Czechia
  • Nemocnice Cesky Krumlov
    Český Krumlov, 381 01, Czechia
  • Donmed s.r.o.
    Ostrava, 710 00, Czechia
  • Milan Kvapil s.r.o., Diabetologicka ambulance
    Prague, 14900, Czechia
  • Medical Plus
    Uherské Hradiště, 686 01, Czechia
  • InnoDiab Forschung Gmbh
    Essen, 45136, Germany
  • Medizentrum Essen Borbeck
    Essen, 45355, Germany
  • Diabetes Zentrum Wilhelmsburg
    Hamburg, 21109, Germany
  • AmBeNet GmbH
    Leipzig, 04107, Germany
  • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut
    Leipzig, 04249, Germany
  • Medicover Neuroendokrinologie
    Munich, 81667, Germany
  • RED-Institut GmbH
    Oldenburg, 23758, Germany
  • Hasegawa Medicine Clinic
    Chitose, 066-0032, Japan
  • The Institute of Medical Science, Asahi Life Foundation
    Chūōku, 103-0002, Japan
  • Tokyo-Eki Center-building Clinic
    Chūōku, 103-0027, Japan
  • Fukuwa Clinic
    Chūōku, 104-0031, Japan
  • Tokuyama Clinic
    Mihama-ku,Chiba City, 261-0004, Japan
  • Medical Corporation Heishinkai ToCROM Clinic
    Shinjuku-ku, 160-0008, Japan
  • Medical Corporation Heishinkai OCROM Clinic
    Suita-shi, 565-0853, Japan
  • Olive Takamatsu Medical Clinic
    Takamatsu, 760-0076, Japan
  • Shimokitazawa Tomo Clinic
    Tokyo, 155-0031, Japan
  • Tsuchiura Medical & Health Care Center
    Tsuchiura, 300-0012, Japan
  • Noritake Clinic
    Ushiku, 300-1207, Japan
  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
    Yamato-shi, 242-0004, Japan
  • Yokohama Minoru Clinic
    Yokohama, 232-0064, Japan
  • Puerto Rico Health and Wellness Institute
    Dorado, 00646, Puerto Rico
  • Isis Clinical Research Center
    Guaynabo, 00968, Puerto Rico
08

References and documents

Individual participant data

Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Supporting information: Study protocol, Sap, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06972459
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
May 15, 2025
Start date
May 15, 2025
Primary completion
Aug 2027 (estimated)
Completion
Aug 2027 (estimated)
Last update
Jul 29, 2026

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion