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ObesityPhase 3NCT06972459

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

A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 80 sites in 7 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Overweight
What is being tested?
Orforglipron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
800 participants
Where
80 sitesin 7 countries
Study dates
15 May 2025to Aug 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

80 sites in 7 countries.

80 sites in 7 countries

United States35 sites

  • Great Lakes Research Group, Inc.

    Bay City, Michigan, 48706

  • Javara - Nevada Health Centers - Carson City

    Carson City, Nevada, 89706

  • University of North Carolina Medical Center

    Chapel Hill, North Carolina, 27514

  • Javara - Tryon Medical Partners

    Charlotte, North Carolina, 28210

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon, 97330

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Accel Research Sites - NeuroStudies Clinical Research Unit

    Decatur, Georgia, 30030

  • Care Access - Decatur

    Decatur, Georgia, 30030

  • Accel Research Sites - DeLand Clinical Research Unit

    DeLand, Florida, 32720

  • Care Access - Fayetteville

    Fayetteville, North Carolina, 28314

  • Innovation Medical Research Center - Fort Lauderdale

    Fort Lauderdale, Florida, 33316

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012

  • Encore Medical Research

    Hollywood, Florida, 33024

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

  • Activian Clinical Research

    Kingwood, Texas, 77339

  • The Machuca Foundation

    Las Vegas, Nevada, 89101

  • Solaris Clinical Research

    Meridian, Idaho, 83646

  • Texas Valley Clinical Research (TVCR) - Mission

    Mission, Texas, 78572

  • Boeson Research MSO

    Missoula, Montana, 59804

  • Care Access - New Iberia

    New Iberia, Louisiana, 70560

  • West Orange Endocrinology P.A.

    Ocoee, Florida, 34761

  • Clinical Research of Philadelphia

    Philadelphia, Pennsylvania, 19114

  • Endocrine and Metabolic Consultants

    Rockville, Maryland, 20852

  • Norcal Endocrinology & Internal Medicine

    San Ramon, California, 94583

  • Southern California Clinical Research

    Santa Ana, California, 92701

  • Javara - Privia Medical Group Georgia - Savannah

    Savannah, Georgia, 31406

  • Consano Clinical Research, LLC

    Shavano Park, Texas, 78231

  • Javara - Privia Medical Group - Silver Spring

    Silver Spring, Maryland, 20901

  • Frontier Clinical Research, LLC

    Smithfield, Pennsylvania, 15478

  • Clinical Research Institute of Arizona (CRI) - Sun City West

    Sun City West, Arizona, 85375

  • Care Access - Tampa

    Tampa, Florida, 33625

  • Care Access - Thousand Oaks

    Thousand Oaks, California, 91360

  • Novak Clinical Research - Tucson - North La Cholla Boulevard

    Tucson, Arizona, 85741

  • Conquest Research

    Winter Park, Florida, 32789

  • North Georgia Clinical Research

    Woodstock, Georgia, 30189

Other trials in United States

Japan13 sites

  • Hasegawa Medicine Clinic

    Chitose, 066-0032

  • The Institute of Medical Science, Asahi Life Foundation

    Chūōku, 103-0002

  • Tokyo-Eki Center-building Clinic

    Chūōku, 103-0027

  • Fukuwa Clinic

    Chūōku, 104-0031

  • Tokuyama Clinic

    Mihama-ku,Chiba City, 261-0004

  • Medical Corporation Heishinkai ToCROM Clinic

    Shinjuku-ku, 160-0008

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, 565-0853

  • Olive Takamatsu Medical Clinic

    Takamatsu, 760-0076

  • Shimokitazawa Tomo Clinic

    Tokyo, 155-0031

  • Tsuchiura Medical & Health Care Center

    Tsuchiura, 300-0012

  • Noritake Clinic

    Ushiku, 300-1207

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, 242-0004

  • Yokohama Minoru Clinic

    Yokohama, 232-0064

Other trials in Japan

China12 sites

  • Xuanwu Hospital Capital Medical University

    Beijing, 100053

  • Peking University Third Hospital

    Beijing, 100091

  • Sichuan Provincial People's Hospital

    Chengdu, 610072

  • The Second Affiliated Hospital Chongqing Medical University

    Chongqing, 400010

  • Zhujiang Hospital

    Guangzhou, 510280

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, 150001

  • The Second People's Hospital of Hefei

    Hefei, 230011

  • Jinan Central Hospital

    Jinan, 250013

  • The First Affiliated Hospital of Henan University of Science &Technology

    Luoyang Shi, 471003

  • Zhongda Hospital Southeast University

    Nanjing, 210009

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, 210011

  • The Second Hospital of Tianjin Medical University

    Tianjin, 300211

Other trials in China

Germany7 sites

  • InnoDiab Forschung Gmbh

    Essen, 45136

  • Medizentrum Essen Borbeck

    Essen, 45355

  • Diabetes Zentrum Wilhelmsburg

    Hamburg, 21109

  • AmBeNet GmbH

    Leipzig, 04107

  • Gemeinschaftspraxis Dr. Taeschner/Dr. Bonigut

    Leipzig, 04249

  • Medicover Neuroendokrinologie

    Munich, 81667

  • RED-Institut GmbH

    Oldenburg, 23758

Other trials in Germany

Argentina6 sites

  • CARE - Centro de Alergia y Enfermedades Respiratorias

    Buenos Aires, 1414

  • CIPREC

    Buenos Aires, C1119ACN

  • Centro Médico Viamonte

    Buenos Aires, C1120AAC

  • Instituto Centenario

    CABA, 1204

  • Instituto Médico Catamarca IMEC

    Rosario, 2000

  • Centro de Diagnóstico y Rehabilitación (CEDIR)

    Santa Fe, 3000

Other trials in Argentina

Czechia5 sites

  • MUDr. Alena Vachova

    České Budějovice, 37011

  • Nemocnice Cesky Krumlov

    Český Krumlov, 381 01

  • Donmed s.r.o.

    Ostrava, 710 00

  • Milan Kvapil s.r.o., Diabetologicka ambulance

    Prague, 14900

  • Medical Plus

    Uherské Hradiště, 686 01

Other trials in Czechia

Puerto Rico2 sites

  • Puerto Rico Health and Wellness Institute

    Dorado, 00646

  • Isis Clinical Research Center

    Guaynabo, 00968

Other trials in Puerto Rico

About this study

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

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.

Conditions
Obesity, Overweight
Being tested
Orforglipron, Placebo
Medical subject headings
Obesity, Overweight

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrforglipronDrug

    Also called LY3502970

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT06972459
Study groupRoleWhat they receive
Orforglipron Dose 1ExperimentalParticipants will receive orforglipron orally
Receives: Drug: Orforglipron
Orforglipron Dose 2ExperimentalParticipants will receive orforglipron orally
Receives: Drug: Orforglipron
Orforglipron Dose 3ExperimentalParticipants will receive orforglipron orally
Receives: Drug: Orforglipron
Orforglipron Dose 4ExperimentalParticipants will receive orforglipron orally
Receives: Drug: Orforglipron
PlaceboPlacebo comparatorParticipants will receive placebo orally
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change from Baseline in Body Weight

    Measured: Baseline, Week 72

Secondary outcomes (9)

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

    Measured: Baseline up to 72 weeks

  2. Change from Baseline in Waist Circumference

    Measured: Baseline up to 72 weeks

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

    Measured: Baseline, Week 72

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

    Measured: Baseline up to 72 weeks

  5. Percent Change from Baseline in Triglycerides

    Measured: Baseline up to 72 weeks

  6. Change from Baseline in Hemoglobin A1c (HbA1c)

    Measured: Baseline up to 72 weeks

  7. Change from Baseline in Fasting Glucose

    Measured: Baseline up to 72 weeks

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

    Measured: Baseline, Week 72

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

    Measured: Predose through Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 May 2025
  2. Study start15 May 2025
  3. Primary completionAug 2027 (estimated)
  4. Study completionAug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Phase 3b
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06972459
Sponsor's protocol ID
27361
Other IDs
2025-521098-14-00, J2A-MC-GZP1, J2A-MC-GZPO, 2025
Status last verified
Jul 2026
First submitted
7 May 2025
Last updated
29 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orforglipron in people with Obesity and Overweight, run by Eli Lilly and Company at 80 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States, Japan, China, Germany, Argentina and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change from Baseline in Body Weight (time frame: Baseline, Week 72). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06972459.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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