A Study of Orforglipron in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

September 3, 2026 updated by: Eli Lilly and Company

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral LY3502970 Compared With Placebo in Adult Participants With Obesity or Overweight and Type 2 Diabetes (ATTAIN-2)

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult participants with obesity or overweight and type 2 diabetes. The study will last about 77 weeks and may include up to 22 visits.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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.
1613

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

  • Argentina
      • Buenos Aires, Argentina, 1012
        • CONEXA Investigacion Clinica S.A.
      • Córdoba, Argentina, 5000
        • Centro Diabetológico Dr. Waitman
      • Córdoba, Argentina, X50004FHP
        • Clínica Universitaria Reina Fabiola
      • Santa Fe, Argentina, 3000
        • Centro de Diagnóstico y Rehabilitación (CEDIR)
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, C1128AAF
        • Mautalen Salud e investigación
    • Ciudad Aut
      • C.a.b.a., Ciudad Aut, Argentina, C1205AAO
        • CEMEDIAB
    • Ciudad Autónoma de Buenos Aire
      • CABA, Ciudad Autónoma de Buenos Aire, Argentina, 1204
        • Instituto Centenario
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto de Investigaciones Clinicas Rosario
      • Rosario, Santa Fe Province, Argentina, 2000
        • Instituto Médico Fundación Grupo Colaborativo Rosario Investigación y Prevención Medica
      • Venado Tuerto, Santa Fe Province, Argentina, 2600
        • Sanatorio San Martin
    • Tucumán Province
      • SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • Australia
    • New South Wales
      • Botany, New South Wales, Australia, 2019
        • Emeritus Research
      • Merewether, New South Wales, Australia, 2291
        • The AIM Centre / Hunter Diabetes Centre
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Royal Brisbane and Women's Hospital
      • Brisbane, Queensland, Australia, 4064
        • Core Research Group
      • Meadowbrook, Queensland, Australia, 4131
        • Logan Hospital
    • South Australia
      • Oaklands Park, South Australia, Australia, 5046
        • Southern Adelaide Diabetes & Endocrine services
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Heidelberg West, Victoria, Australia, 3081
        • Austin Health - Repatriation Hospital
      • Melbourne, Victoria, Australia, 3004
        • Baker IDI Heart and Diabetes Institute - Melbourne
    • Western Australia
      • Joondalup, Western Australia, Australia, 6027
        • Advara HeartCare Joondalup
  • Brazil
      • São Paulo, Brazil, 04266-010
        • CEPIC - Centro Paulista de Investigação Clínica
    • Federal District
      • Brasília, Federal District, Brazil, 71625-175
        • Centro de Pesquisa Clinica do Brasil
    • Goiás
      • Goiânia, Goiás, Brazil, 74230-035
        • Cendi - Endocrinologia e Diabetes
    • Rio Grande do Sul
      • Passo Fundo, Rio Grande do Sul, Brazil, 99010-120
        • Instituto Méderi de Pesquisa e Saúde
    • Rio de Janeiro
      • Volta Redonda, Rio de Janeiro, Brazil, 27253-003
        • Instituto Lóbus
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-080
        • Instituto de Pesquisa Clínica de Campinas
      • Marília, São Paulo, Brazil, 17504-072
        • Centro de Pesquisa Clínica de Marília - CPCLIM
      • Santo André, São Paulo, Brazil, 09080-110
        • Pesquisare Saúde
  • 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, 400014
        • Chongqing General Hospital
    • Guangdong
      • Shenzhen, Guangdong, China, 518020
        • Shenzhen People's 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
      • Nanjing, Jiangsu, China, 210008
        • Jiangsu Province Official Hospital
      • Nantong, Jiangsu, China, 226001
        • Nantong First People's Hospital
      • Wuxi, Jiangsu, China, 214023
        • Wuxi People's Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Jiangxi Provincial People's Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116033
        • Dalian Municipal Central Hospital Affiliated of Dalian Medical University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Jinan Central Hospital
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300052
        • Tianjin Medical University General Hospital
      • Tianjin, Tianjin Municipality, China
        • Tianjin Medical University Zhu Xianyi Memorial Hospital
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • The First People's Hospital of Yunnan Province
  • Czechia
      • Hradec Králové, Czechia, 500 12
        • Endokrinologie MUDr. Rehorkova s.r.o.
      • Pilsen, Czechia, 326 00
        • MUDr. Jitka Zemanová - diabetologie a interna s.r.o.
      • Český Krumlov, Czechia, 381 01
        • Nemocnice Cesky Krumlov
    • Central Bohemia
      • Příbram, Central Bohemia, Czechia, 26201
        • Milan Kvapil s.r.o., Diabetologicka ambulance Pribram
    • Moravskosl
      • Krnov, Moravskosl, Czechia, 79401
        • MUDr. Tomas Edelsberger
    • Pardubice
      • Pardubice V, Pardubice, Czechia, 530 02
        • Diahelp s.r.o
    • Plzeň-město
      • Pilsen, Plzeň-město, Czechia, 301 00
        • Dialine - Interni a diabetologicka ambulance
    • Praha 1
      • Prague, Praha 1, Czechia, 11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 4
      • Prague, Praha 4, Czechia, 14900
        • Milan Kvapil s.r.o., Diabetologicka ambulance
    • Praha 8
      • Prague, Praha 8, Czechia, 18100
        • ResTrial s.r.o.
    • Praha-západ
      • Jílové u Prahy, Praha-západ, Czechia, 252 42
        • MUDr. Sabina Palova
    • South Bohemian Region
      • České Budějovice, South Bohemian Region, Czechia, 37011
        • MUDr. Alena Váchová
  • Germany
      • Gelnhausen, Germany, 63571
        • Diabetes Zentrum Dr. Tews
      • Hamburg, Germany, 21109
        • Diabetes Zentrum Wilhelmsburg
    • Bavaria
      • München, Bavaria, Germany, 80809
        • CDG Studienambulanz Hartard
      • Wallerfing, Bavaria, Germany, 94574
        • Gemeinschaftspraxis Dr. med. Josef und Wilma Großkopf
    • Hesse
      • Pohlheim, Hesse, Germany, 35415
        • Ceda-Research
    • Nordrhein-
      • Münster, Nordrhein-, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 50937
        • Universitaetsklinikum Koeln
      • Essen, North Rhine-Westphalia, Germany, 45355
        • Medizentrum Essen Borbeck
      • Essen, North Rhine-Westphalia, Germany, 45136
        • InnoDiab Forschung GmbH
    • Saxony
      • Leipzig, Saxony, Germany, 04107
        • AmBeNet GmbH
      • Pirna, Saxony, Germany, 01796
        • Arztpraxis Christine Kosch Pirna
    • Saxony-Anhalt
      • Hohenmölsen, Saxony-Anhalt, Germany, 06679
        • Hausarzt- und Diabetologische Schwerpunktpraxis Hohenmölsen - Weiβenfels
      • Magdeburg, Saxony-Anhalt, Germany, 39120
        • SMO.MD GmbH
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23562
        • Universität zu Lübeck - Institut für Endokrinologie und Diabetes
      • Oldenburg in Holstein, Schleswig-Holstein, Germany, 23758
        • Red-Institut GmbH
  • Greece
      • Thessaloniki, Greece, 564 29
        • 424 Military General Training Hospital
    • Attikí
      • Athens, Attikí, Greece, 151 25
        • Athens Medical Center
    • Kentrikí Makedonía
      • Thessaloniki, Kentrikí Makedonía, Greece, 54642
        • Ippokrateio General Hospital of Thessaloniki
    • Thessaloníki
      • Thessaloniki, Thessaloníki, Greece, 570 01
        • Thermi Clinic
      • Thessaloniki, Thessaloníki, Greece, 546 45
        • Euromedica General Clinic of Thessaloniki
      • Thessaloniki, Thessaloníki, Greece, 564 29
        • Papageorgiou General Hospital of Thessaloniki
    • Thessalía
      • Larissa, Thessalía, Greece, 41110
        • University General Hospital of Larissa
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560092
        • Medstar Speciality Hospital
      • Hubli, Karnataka, India, 580021
        • Karnataka Institute of Medical Sciences
    • Madhya Pradesh
      • Indore, Madhya Pradesh, India, 452010
        • TOTALL Diabetes Hormone Institute
    • Maharashtra
      • Mumbai, Maharashtra, India, 400008
        • Topiwala National Medical College & B. Y. L. Nair Charitable Hospital
      • Mumbai, Maharashtra, India, 400058
        • BSES MG Hospital
      • Nagpur, Maharashtra, India, 441108
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
      • Pune, Maharashtra, India, 411004
        • Sahyadri Super Speciality Hospital
    • Tamil Nadu
      • Madurai, Tamil Nadu, India, 625020
        • Arthur Asirvatham Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500082
        • Kumudini Devi Diabetes Research Center
  • Puerto Rico
    • PR
      • Bayamón, PR, Puerto Rico, 00959
        • Advanced Clinical Research, LLC
      • Guaynabo, PR, Puerto Rico, 00968
        • Isis Clinical Research Center
  • South Korea
    • Kang-won-do
      • Wŏnju, Kang-won-do, South Korea, 26426
        • Yonsei University-Wonju Severance Christian Hospital
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, South Korea, 13620
        • Seoul National University Bundang Hospital
    • Kyǒngsangbuk-do
      • Gyeongsan-si, Kyǒngsangbuk-do, South Korea, 42415
        • Yeungnam Univeristy Medical Center
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 06591
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 134-090
        • Kyung Hee University Hospital at Gangdong
  • United States
    • Alabama
      • Pelham, Alabama, United States, 35124
        • Cahaba Research - Pelham
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Novak Clinical Research - Tucson - North La Cholla Boulevard
      • Yuma, Arizona, United States, 85364
        • Yuma Clinical Trials
    • California
      • Escondido, California, United States, 92025
        • AMCR Institute
      • 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
      • Tustin, California, United States, 92780
        • University Clinical Investigators, Inc.
    • Florida
      • Hollywood, Florida, United States, 33024
        • Encore Medical Research
      • Jacksonville, Florida, United States, 32216
        • East Coast Institute for Research, LLC
      • Margate, Florida, United States, 33063
        • South Florida Clinical Research Institute
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research, Inc.
    • Georgia
      • Lawrenceville, Georgia, United States, 30046
        • Balanced Life Health Care Solutions/SKYCRNG
      • Roswell, Georgia, United States, 30076
        • Endocrine Research Solutions, Inc.
      • Woodstock, Georgia, United States, 30189
        • North Georgia Clinical Research
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Pacific Diabetes & Endocrine Center
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Solaris Clinical Research
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Iowa Diabetes and Endocrinology Research Center
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • MedStar Good Samaritan Hospital
    • Michigan
      • Troy, Michigan, United States, 48098
        • Arcturus Healthcare , PLC, Troy Internal Medicine Research Division
    • Missouri
      • City of Saint Peters, Missouri, United States, 63303
        • StudyMetrix Research
    • Nevada
      • Las Vegas, Nevada, United States, 89128
        • Las Vegas Medical Research
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • IMA Clinical Research
    • New York
      • Albany, New York, United States, 12203
        • Albany Medical College, Division of Community Endocrinology
      • Albany, New York, United States, 12208
        • Albany Stratton VA Medical Center
      • Long Island City, New York, United States, 11106
        • NYC Research INC
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
        • Accellacare - Raleigh
    • Oregon
      • Portland, Oregon, United States, 97210
        • Summit Headlands
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Alliance for Multispecialty Research, LLC
    • Texas
      • Dallas, Texas, United States, 75230
        • Velocity Clinical Research, Dallas
      • DeSoto, Texas, United States, 75115
        • Epic Medical Research - DeSoto
      • Denison, Texas, United States, 75020
        • Soma Clinical Trials
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, LLC
      • San Antonio, Texas, United States, 78230
        • VIP Trials
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Center
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research
    • Washington
      • Tacoma, Washington, United States, 98405
        • Universal Research Group

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 body mass index (BMI) ≥27.0 kilogram/square meter (kg/m²).
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

  • Have a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of:

    • either diet/exercise alone or
    • up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA).

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
  • Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors).
  • Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) 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
Participants received matching placebo capsule orally once daily (QD). Treatment was initiated with placebo corresponding to 1 milligram (mg) equivalent to Orforglipron, with dose escalation every 4 weeks to maintain blinding, and was continued through Week 72, unless dose modification was required.
Drug: Placebo
Administered orally
Experimental: 6 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 6 mg, which was maintained through Week 72, unless dose modification was required.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: 12 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 12 mg, which was maintained through Week 72, unless dose modification was required.
Drug: Orforglipron
Administered orally
Other Names:
  • LY3502970
Experimental: 36 mg Orforglipron QD
Participants received oral orforglipron capsule once daily. Treatment was initiated at 1 mg once daily, with dose escalation every 4 weeks to a target dose of 36 mg, which was maintained through Week 72, unless dose modification was required.
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
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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral antihyperglycemic medications (AHMs) classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). 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
Percentage of Participants Who Achieved With Greater Than or Equal to (≥) 5% Body Weight Reduction From Baseline
Time Frame: Baseline to Week 72
Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Percentage of Participants Who Achieved ≥10% Body Weight Reduction From Baseline
Time Frame: Baseline to Week 72
Percentage of participants with ≥10% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Percentage of Participants Who Achieved ≥15% Body Weight Reduction From Baseline
Time Frame: Baseline to Week 72
Percentage of participants with ≥15% body weight reduction was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Change From Baseline in Waist Circumference
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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Hemoglobin A1c (HbA1c) %
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 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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Change From Baseline in Fasting Serum Glucose (FSG)
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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<6.5%)
Time Frame: Baseline to Week 72
Percentage of participants who achieved hemoglobin A1c (HbA1c<6.5%) was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Percentage of Participants Who Achieved Hemoglobin A1c (HbA1c) Target Value (<7.0%)
Time Frame: Baseline to Week 72
Percentage of participants who achieved hemoglobin A1c (HbA1c<7%) was analysed by Logistic regression with the following variables: region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality).
Baseline to Week 72
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). 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)
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 region + Baseline*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). Variance-covariance structure for change from baseline was unstructured.
Baseline, Week 72
Percent Change From Baseline in Fasting Insulin
Time Frame: Baseline, Week 72
  • Fasting Insulin is a test used to measure the amount of insulin in the body.
  • Values represented under "Geometric Least Squares Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure 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)
Time Frame: Baseline, Week 72
Values represented under "Geometric Least Squares Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure was unstructured.
Baseline, Week 72
Percent Change From Baseline in Triglycerides (Pooled Doses of Orforglipron 6 mg, 12 mg and 36 mg)
Time Frame: Baseline, Week 72
Values represented under "Geometric Least Square Mean" are model-based estimates (MBE) of the unconditional average treatment effect. For post-baseline measures, MBE was calculated using a mixed-model repeated measures (MMRM) on log-transformed values, defined on log-transformed values, defined as log (Actual Measurement/Baseline) + Region + log (Baseline)*Time*Treatment + Strata*Time*Treatment in the model. Strata were defined by joint levels of sex (female, male) and background oral AHMs classified according to their potential effect on body weight (promoting weight gain, weight reduction, or weight neutrality). The variance-covariance structure 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)
Time Frame: Baseline, Week 72
The SF-36v2 acute form, (1-week recall version) assesses participants' health-related quality of life on 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

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 9 AM - 5 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.
August 8, 2025

Study Completion (Actual)

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.
August 8, 2025

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 15, 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 15, 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 24, 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.
September 4, 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.
September 3, 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.
September 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.
  • 18560 (City of Hope Comprehensive Cancer Center)
  • J2A-MC-GZGQ (Other Identifier: Eli Lilly and Company)
  • 2022-502837-24-00 (Other Identifier: Eli Lilly and Company)
  • U1111-1289-8799 (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

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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