A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

July 23, 2026 updated by: Eli Lilly and Company

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

This study will investigate the efficacy and safety of once daily oral orforglipron in adult participants with obesity or overweight with weight-related comorbidities. The study has two phases: a main phase and an extension phase. The main phase of the study lasted 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3127

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: ClinicalTrials.gov@lilly.com

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 22061-080
        • Hospital São Lucas de Copacabana
      • São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clínica
      • São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigacao Clinica
      • São Paulo, Brazil, 05403-000
        • Hospital das Clinicas FMUSP
    • Ceará
      • Fortaleza, Ceará, Brazil, 60430-350
        • Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055450
        • CEDOES
    • Maranhão
      • Bequimão, Maranhão, Brazil, 65060-645
        • Hospital São Domingos
    • Paraná
      • Curitiba, Paraná, Brazil, 80030-480
        • Cline Research Center
      • Curitiba, Paraná, Brazil, 80045170
        • Quanta Diagnóstico e Terapia
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90430-001
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-803
        • Centro de Pesquisa Sao Lucas
      • Jaú, São Paulo, Brazil, 17201130
        • CECIP - Centro de Estudos do Interior Paulista
      • São Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Centro Multidisciplinar de Estudos Clinicos
      • Votuporanga, São Paulo, Brazil, 15501-405
        • Integral Pesquisa e Ensino
  • China
    • Anhui
      • Hefei, Anhui, China, 230011
        • The Second People's Hospital of Hefei
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100853
        • Chinese PLA General Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 404117
        • Chongqing General Hospital
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen People's Hospital
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • The Fourth Affiliated Hospital of Harbin Medical University
    • Henan
      • Luoyang Shi, Henan, China, 471003
        • The First Affiliated Hospital of Henan University of Science &Technology
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China, 210011
        • The Second Affiliated Hospital of Nanjing Medical University
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
      • Zhenjiang, Jiangsu, China, 212000
        • Affiliated Hospital of Jiangsu University
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 201800
        • Jiading District Central Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin Municipality, China, 300134
        • Tianjin Medical University Zhu Xianyi Memorial Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • The First People's Hospital of Yunnan Province
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310013
        • Zhejiang Hospital
      • Ningbo, Zhejiang, China, 315010
        • Ningbo First Hospital
  • India
    • Andhra Pradesh
      • Guntur, Andhra Pradesh, India, 522001
        • Endolife Speciality Hospitals
    • Karnataka
      • Bangalore, Karnataka, India, 560002
        • Victoria Hospital, Bangalore Medical College And Research Institute
      • Mysore, Karnataka, India, 570001
        • Mysore Medical College
    • Maharashtra
      • Nagpur, Maharashtra, India, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Nagpur, Maharashtra, India, 440015
        • Central India Cardiology and Research Institute
      • Pune, Maharashtra, India, 411004
        • Deenanath Mangeshkar Hospital & Research Centre
      • Pune, Maharashtra, India, 411004
        • Sahyadri Super Speciality Hospital
      • Pune, Maharashtra, India, 411057
        • Lifepoint Multispeciality Hospital
  • Japan
      • Fukuoka, Japan, 812-0025
        • Boocs Clinic Fukuoka
      • Osaka, Japan, 530-0001
        • Osaka Nishiumeda Clinic
    • Fukuoka
      • Wakasugi, Fukuoka, Japan, 811-2310
        • Oishi Clinic
    • Hiroshima
      • Aki-gun, Hiroshima, Japan, 735-0017
        • Mazda Hospital
    • Ibaraki
      • Tsuchiura, Ibaraki, Japan, 300-0012
        • Tsuchiura Medical & Health Care Center
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 760-0076
        • NTT Nishinihon Takamatsu Clinic
      • Zentsujichó, Kagawa-ken, Japan, 765-0071
        • Iwamoto Internal Medicine Clinic
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 232-0064
        • Yokohama Minoru Clinic
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Saitama
      • Sōka, Saitama, Japan, 340-0015
        • Sugiura Internal Medicine Clinic
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 120-0022
        • Adachi Kyosai Hospital
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Tokyo-Eki Center-building Clinic
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Fukuwa Clinic
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Medical Corporation Chiseikai Tokyo Center Clinic
      • Meguro-ku, Tokyo, Japan, 153-0053
        • Yutenji Medical Clinic
      • Mitaka, Tokyo, Japan, 181-0013
        • Kanno Naika
      • Setagaya-ku, Tokyo, Japan, 155-0031
        • Shimokitazawa Tomo Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Heishinkai Medical Group ToCROM Clinic
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Dorado Medical Complex
    • PR
      • San Juan, PR, Puerto Rico, 00917
        • GCM Medical Group, PSC - Hato Rey Site
  • Slovakia
      • Bratislava, Slovakia, 831 03
        • MediTask
    • Banská Bystrica Region
      • Lučenec, Banská Bystrica Region, Slovakia, 984 01
        • Nemocnica s poliklinikou Lucenec
    • Bratislava Region
      • Bratislava, Bratislava Region, Slovakia, 811 08
        • Metabol KLINIK
    • Košice Region
      • Košice, Košice Region, Slovakia, 04001
        • Human Care s.r.o.
      • Trebišov, Košice Region, Slovakia, 075 01
        • ARETEUS s.r.o.
    • Košický Kr
      • Rožňava, Košický Kr, Slovakia, 048 01
        • DIAB sro
    • Presov
      • Sabinov, Presov, Slovakia, 083 01
        • MEDI-DIA s.r.o.
    • Trenčín Region
      • Púchov, Trenčín Region, Slovakia, 020 01
        • DIA-MED CENTRUM s.r.o.
  • South Korea
    • Incheon-gw
      • Namdong-gu, Incheon-gw, South Korea, 21565
        • Gachon University Gil Medical Center
    • Kyǒnggi-do
      • Ansan-si, Kyǒnggi-do, South Korea, 15355
        • Korea university Ansan hospital
      • Anyang-si, Kyǒnggi-do, South Korea, 14068
        • Hallym University Sacred Heart Hospital
      • Suwon, Kyǒnggi-do, South Korea, 16499
        • Ajou University Hospital
    • Kyǒngsangnam-do
      • Busan, Kyǒngsangnam-do, South Korea, 50612
        • Pusan National University Yangsan Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 03080
        • Seoul National University Hospital
    • Taejǒn-Kwangyǒkshi
      • Seogu, Taejǒn-Kwangyǒkshi, South Korea, 35365
        • Konyang University Hospital
  • Spain
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
    • A Coruña [La Coruña]
      • A Coruña, A Coruña [La Coruña], Spain, 15006
        • CHUAC-Complejo Hospitalario Universitario A Coruña
      • Ferrol, A Coruña [La Coruña], Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol (CHUF)- Hospital Naval
    • Almería
      • Almería, Almería, Spain, 04009
        • Centro Periferico De Especialidades Bola Azul
    • Andalusia
      • Málaga, Andalusia, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
      • Seville, Andalusia, Spain, 41010
        • Hospital Quiron Infanta Luisa
    • Barcelona [Barcelona]
      • Badalona, Barcelona [Barcelona], Spain, 08916
        • Hospital Germans Trias i Pujol
      • Barcelona, Barcelona [Barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Barcelona [Barcelona], Spain, 08022
        • Centro Médico Teknon
    • Castille and León
      • Valladolid, Castille and León, Spain, 47010
        • Hospital Clínico Universitario de Valladolid
    • Cádiz
      • Sanlúcar de Barrameda, Cádiz, Spain, 11540
        • Hospital Virgen del Camino
      • Villamartín, Cádiz, Spain, 11650
        • Hospital Virgen de las Montañas
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Hospital General Universitario de Valencia
  • Taiwan
      • Changhua, Taiwan, 50006
        • Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Tainan, Taiwan, 704
        • National Cheng Kung University Hospital
    • Chiayi
      • Chiayi City, Chiayi, Taiwan, 600
        • Chiayi Christian Hospital
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital at Kaohsiung
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85225
        • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
      • Sun City West, Arizona, United States, 85375
        • Clinical Research Institute of Arizona (CRI) - Sun City West
    • California
      • Concord, California, United States, 94520
        • John Muir Physician Network Research Center
      • Escondido, California, United States, 92025
        • AMCR Institute
      • Greenbrae, California, United States, 94904
        • NorCal Medical Research, Inc
      • Huntington Park, California, United States, 90255
        • Velocity Clinical Research, Huntington Park
      • Los Angeles, California, United States, 90057
        • Velocity Clinical Research, Westlake
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • San Ramon, California, United States, 94583
        • Norcal Endocrinology & Internal Medicine
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus
    • Florida
      • Miami, Florida, United States, 33186
        • New Age Medical Research Corporation
      • Miramar, Florida, United States, 33027
        • South Broward Research
      • Ocala, Florida, United States, 34470
        • Renstar Medical Research
      • Tampa, Florida, United States, 33619
        • Jedidiah Clinical Research - Tampa - Bay Plaza
      • Winter Park, Florida, United States, 32789
        • Clinical Site Partners, LLC dba Flourish Research
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Physicians Research Associates
      • Macon, Georgia, United States, 31210
        • East Coast Institute for Research, LLC
      • Union City, Georgia, United States, 30291
        • Rophe Adult and Pediatric Medicine/SKYCRNG
    • Hawaii
      • Honolulu, Hawaii, United States, 96814
        • East-West Medical Research Institute
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Elite Clinical Trials
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Clinical Research Center
      • Topeka, Kansas, United States, 66606
        • Cotton O'Neil Diabetes & Endocrinology
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Pennington Biomedical Research Center
      • Lake Charles, Louisiana, United States, 70601
        • Care Access - Lake Charles
    • Maryland
      • Hyattsville, Maryland, United States, 20782
        • MedStar Health Research Institute (MedStar Physician Based Research Network)
      • Rockville, Maryland, United States, 20852
        • Endocrine and Metabolic Consultants
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Mississippi
      • Ridgeland, Mississippi, United States, 39157
        • SKY Integrative Medical Center/SKYCRNG
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Medical Research
    • New York
      • Lake Success, New York, United States, 11042
        • Long Island Cardiovascular Consultants
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Austin, Texas, United States, 78731
        • Texas Diabetes & Endocrinology, P.A.
      • Dallas, Texas, United States, 75251
        • Cedar Health Research
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • Dallas, Texas, United States, 75208
        • Thyroid, Endocrinology, and Diabetes
      • Houston, Texas, United States, 77054
        • Juno Research
      • Shavano Park, Texas, United States, 78231
        • Consano Clinical Research, LLC
      • Wylie, Texas, United States, 75098
        • Soma Clinical Trials
    • Utah
      • Draper, Utah, United States, 84020
        • Physicians' Research Options
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Health Research of Hampton Roads, Inc.
    • Washington
      • Redmond, Washington, United States, 98052
        • Eastside Research Associates

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a BMI

    • ≥30.0 kilogram/square meter (kg/m²),

    • ≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:

      • Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion Criteria:

  • Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
  • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
  • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
  • Have had a history of chronic or acute pancreatitis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron-matching placebo, administered orally once daily (QD), for a period of 72 weeks.
Drug: Placebo
Administered orally.
Experimental: 6 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 milligrams (mg) and escalated every 4 weeks until reaching a dose of 6 mg at week 8, which was then maintained up to week 72.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970
Experimental: 12 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 12 mg at week 12, which was then maintained up to week 72.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970
Experimental: 36 mg Orforglipron
Primary Treatment Period (Week 0-Week 72): Participants with normoglycemia or prediabetes at the time of randomization received orforglipron, administered orally QD, starting at a dose of 1 mg and escalated every 4 weeks until reaching a dose of 36 mg at week 20, which was then maintained up to week 72.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percent Change From Baseline in Body Weight (Primary Treatment Period)
Time Frame: Baseline, Week 72
Values represented under "Least Squares (LS) Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Waist Circumference (Primary Treatment Period)
Time Frame: Baseline, Week 72
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
Time Frame: Baseline, Week 72
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percent Change From Baseline in Non-High Density Lipoprotein (Non-HDL) Cholesterol (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
Time Frame: Baseline, Week 72
Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
Time Frame: Baseline, Week 72
Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in HbA1c (Primary Treatment Period)
Time Frame: Baseline, Week 72
  • Hemoglobin A1c (HbA1c) is the glycosylated fraction of hemoglobin A, measured to reflect average plasma glucose concentration over prolonged periods of time.
  • Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Fasting Serum Glucose (FSG) (Primary Treatment Period)
Time Frame: Baseline, Week 72
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percent Change From Baseline in Fasting Insulin (Primary Treatment Period)
Time Frame: Baseline, Week 72
  • Fasting insulin is a blood test that measures the level of insulin in the blood after fasting.
  • Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with log (Actual Measurement/Baseline) = geographic region, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
Time Frame: Baseline, Week 72
Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a mixed-model repeated measures (MMRM) for post-baseline measures with geographic region, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of Sex (female, male) and prediabetes status (yes, no). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical Component and Mental Component) Scores - (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg) - Primary Treatment Period
Time Frame: Baseline, Week 72
The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.
Baseline, Week 72
Percent Change From Baseline in Body Weight (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)
Time Frame: Baseline, Week 176
Baseline, Week 176
Time to Onset of Type 2 Diabetes (Primary and Additional Treatment Periods: Participants With Prediabetes at Randomization)
Time Frame: Baseline through Week 176, Baseline through Week 190
Baseline through Week 176, Baseline through Week 190

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eli Lilly and Company

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 5, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 25, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18559
  • J2A-MC-GZGP (Other Identifier: Eli Lilly and Company)
  • 2022-502839-19-00 (Other Identifier: Eli Lilly and Company)
  • U1111-1289-8877 (Other Identifier: UTN Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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