A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (ACHIEVE-1)

April 15, 2024 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 Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

520

Phase

  • 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

  • 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

  • China
    • Anhui
      • Wuhu, Anhui, China, 241001
        • Active, not recruiting
        • Wannan Medical College Yijishan Hospital
    • Beijing
      • Beijing, Beijing, China, 100000
        • Active, not recruiting
        • Luhe Hospital
      • Beijing, Beijing, China, 100730
        • Active, not recruiting
        • Beijing Hospital
      • Beijing, Beijing, China, 101200
        • Active, not recruiting
        • Beijing Pinggu District Hospital
    • Guangdong
      • Foshan, Guangdong, China, 528399
        • Active, not recruiting
        • Shunde Hospital of Southern Medical Univesity
      • Huizhou, Guangdong, China, 516001
        • Active, not recruiting
        • Huizhou Municipal Central Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150001
        • Active, not recruiting
        • The Fourth Hospital of Harbin Medical University
    • Henan
      • Nanyang, Henan, China, 473014
        • Active, not recruiting
        • NanYang First people's hospital
      • Zhengzhou, Henan, China, 450014
        • Active, not recruiting
        • The Second Affiliated Hospital Of Zhengzhou University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210006
        • Active, not recruiting
        • Nanjing First Hospital
      • Nanjing, Jiangsu, China, 210011
        • Active, not recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
      • Zhenjiang, Jiangsu, China, 212000
        • Active, not recruiting
        • Affiliated Hospital of Jiangsu University
    • Shandong
      • Jinan, Shandong, China, 250013
        • Active, not recruiting
        • Jinan Central Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 201200
        • Active, not recruiting
        • Pudong New Area People's Hospital Shanghai
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Active, not recruiting
        • West China Hospital of Sichuan University
  • India
    • Gujarat
      • Ahmedabad, Gujarat, India, 380016
        • Not yet recruiting
        • B. J. Medical College & Civil Hospital
        • Contact:
          • Phone Number: 919924643799
        • Principal Investigator:
          • Kartikeya Parmar
      • Baroda, Gujarat, India, 390021
        • Recruiting
        • GMERS Medical College and General Hospital
        • Contact:
          • Phone Number: 912652772799
        • Principal Investigator:
          • Meenakshi Shah
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • Recruiting
        • M S Ramaiah Medical College and Hospitals
        • Contact:
          • Phone Number: 918197132111
        • Principal Investigator:
          • Dr Chitra Selvan
      • Bangalore, Karnataka, India, 560092
        • Recruiting
        • Medstar Speciality Hospital
        • Contact:
          • Phone Number: 09884457106
        • Principal Investigator:
          • ambrish c
    • Maharashtra
      • Mumbai, Maharashtra, India, 400058
        • Recruiting
        • BSES MG hospital
        • Principal Investigator:
          • MANOJ CHAWLA
      • Nagpur, Maharashtra, India, 441108
        • Recruiting
        • All India Institute of Medical Sciences (AIIMS) - Nagpur
        • Contact:
          • Phone Number: 9930805548
        • Principal Investigator:
          • Udit Narang
      • Pune, Maharashtra, India, 411001
        • Recruiting
        • Grant Medical Foundation - Ruby Hall Clinic
        • Principal Investigator:
          • Sanjay Chunilal Agarwal
        • Contact:
          • Phone Number: 9822091220
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600086
        • Recruiting
        • Madras Diabetes Research Foundation
        • Contact:
          • Phone Number: 9840134505
        • Principal Investigator:
          • VISWANATHAN MOHAN
    • Telangana
      • Hyderabad, Telangana, India, 500072
        • Recruiting
        • Kumudini Devi Diabetes Research Center
        • Contact:
          • Phone Number: 917842041355
        • Principal Investigator:
          • Vishnupriya Rao Paturi
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Recruiting
        • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital
        • Principal Investigator:
          • Sujoy Ghosh
  • Japan
      • Kumamoto, Japan, 860-0863
        • Active, not recruiting
        • Morinaga Ueno Clinic
      • Oita, Japan, 870-0039
        • Active, not recruiting
        • Abe Clinic
    • Chiba
      • Mihama-ku,Chiba City, Chiba, Japan, 261-0004
        • Active, not recruiting
        • Tokuyama clinic
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 805-8508
        • Active, not recruiting
        • Steel Memorial Yawata Hospital
    • Hokkaido
      • Chitose, Hokkaido, Japan, 066-0032
        • Active, not recruiting
        • Hasegawa Medical Clinic
    • Ibaraki
      • Mito, Ibaraki, Japan, 311-4153
        • Active, not recruiting
        • MinamiAkatsukaClinic
    • Kagawa
      • Zentsuji, Kagawa, Japan, 765-0071
        • Active, not recruiting
        • Iwamoto Internal Medicine Clinic
    • Kanagawa
      • Chigasaki, Kanagawa, Japan, 253-0044
        • Active, not recruiting
        • Hayashi Diabetes Internal Medicine Clinic
      • Yamato-shi, Kanagawa, Japan, 242-0004
        • Active, not recruiting
        • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic
    • Osaka
      • Suita-shi, Osaka, Japan, 565-0853
        • Active, not recruiting
        • Medical Corporation Heishinkai OCROM Clinic
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Active, not recruiting
        • Fukuwa Clinic
      • Chuo-ku, Tokyo, Japan, 103-0002
        • Active, not recruiting
        • The Institute for Adult Disease, Asahi Life Foundation
      • Shinjuku-ku, Tokyo, Japan, 160-0008
        • Active, not recruiting
        • Heishinkai Medical Group ToCROM Clinic
  • Mexico
      • Chihuahua, Mexico, 31110
        • Not yet recruiting
        • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos
        • Contact:
          • Phone Number: 526144398618
        • Principal Investigator:
          • Luis Alejandro Nevarez
      • Querétaro, Mexico, 76100
        • Recruiting
        • PanAmerican Clinical Research - Querétaro - Avenida Antea
        • Contact:
          • Phone Number: 524422502985
        • Principal Investigator:
          • Juan Villagordoa Mesa
      • Veracruz, Mexico, 91900
        • Recruiting
        • FAICIC S. de R.L. de C.V.
        • Contact:
          • Phone Number: 522299327808
        • Principal Investigator:
          • Alejandro Quintin Barrat Hernandez
      • Veracruz, Mexico, 91851
        • Recruiting
        • Instituto Veracruzano en Investigacion Clínica S.C.
        • Contact:
          • Phone Number: 2299323157
        • Principal Investigator:
          • Rosa Isela Luna Ceballos
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44150
        • Recruiting
        • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente
        • Principal Investigator:
          • Maricela Vidrio
      • Guadalajara, Jalisco, Mexico, 44860
        • Recruiting
        • Salud Cardiovascular
        • Contact:
          • Phone Number: 5213336392861
        • Principal Investigator:
          • Agustin Lopez
      • Zapopan, Jalisco, Mexico, 44260
        • Recruiting
        • Centro de Investigacion Medica de Occidente, S.C.
        • Contact:
          • Phone Number: 523312044280
        • Principal Investigator:
          • Emilia Susana Pelayo Orozco
  • Puerto Rico
      • Dorado, Puerto Rico, 00646
        • Recruiting
        • Puerto Rico Health Institute
        • Principal Investigator:
          • Elham Shana Ghorbani
        • Contact:
          • Phone Number: 7877961049
      • San Juan, Puerto Rico, 00926
        • Recruiting
        • Advance Medical Research Center
        • Contact:
          • Phone Number: 5208410241
        • Principal Investigator:
          • Orvil F. Martinez Rivera
  • United States
    • Alabama
      • Sheffield, Alabama, United States, 35660
        • Recruiting
        • Syed Research Consultants Llc
        • Principal Investigator:
          • AARON W KARR
        • Contact:
          • Phone Number: 256-383-4473
    • Arizona
      • Surprise, Arizona, United States, 85378
        • Recruiting
        • Epic Medical Research - Surprise
        • Principal Investigator:
          • Rachel Greatwood
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • Quality of Life Medical & Research Center
        • Contact:
          • Phone Number: 520-731-2333
        • Principal Investigator:
          • Walter S. Patton
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Neighborhood Healthcare Institute of Health
        • Contact:
          • Phone Number: 760-737-6984
        • Principal Investigator:
          • James H Schultz
      • Huntington Park, California, United States, 90255
        • Recruiting
        • National Research Institute - Huntington Park
        • Contact:
          • Phone Number: 323-588-1990
        • Principal Investigator:
          • Stanley H. Hsia
      • Long Beach, California, United States, 90815
        • Recruiting
        • Ark Clinical Research
        • Principal Investigator:
          • Martha G Navarro
      • Los Angeles, California, United States, 90057
        • Recruiting
        • National Research Institute - Wilshire
        • Principal Investigator:
          • David Guzman
        • Contact:
          • Phone Number: 213-483-1800
      • Norco, California, United States, 92860
        • Recruiting
        • Infinity Clinical Research - Norco
        • Contact:
          • Phone Number: 714-252-6689
        • Principal Investigator:
          • Peter Mattar
      • San Ramon, California, United States, 94583
        • Recruiting
        • Norcal Endocrinology & Internal Medicine
        • Principal Investigator:
          • Yshay Shlesinger
        • Contact:
          • Phone Number: 925-552-5280
      • Tustin, California, United States, 92780
        • Recruiting
        • University Clinical Investigators, Inc.
        • Principal Investigator:
          • John Kim
    • Connecticut
      • Cromwell, Connecticut, United States, 06416
        • Recruiting
        • Connecticut Clinical Research - Cromwell
        • Contact:
          • Phone Number: 8606320144
        • Principal Investigator:
          • Charles Brendan Montano
    • Florida
      • Coconut Creek, Florida, United States, 33073
        • Recruiting
        • Invictus Clinical Research Group
        • Contact:
          • Phone Number: 954-842-6434
        • Principal Investigator:
          • Juan F Zapata
      • DeLand, Florida, United States, 32720
        • Recruiting
        • Hillcrest Medical Research
        • Contact:
          • Phone Number: 386-999-7616
        • Principal Investigator:
          • John M Hill
      • Maitland, Florida, United States, 32751
        • Recruiting
        • K2 Medical Research
        • Contact:
          • Phone Number: 407-810-2790
        • Principal Investigator:
          • Neel Patel
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Global Health Research Center, Inc.
        • Contact:
          • Phone Number: 305-824-0026
        • Principal Investigator:
          • Maray Rocher
      • Ocoee, Florida, United States, 34761
        • Recruiting
        • West Orange Endocrinology
        • Contact:
          • Phone Number: 4074804830
        • Principal Investigator:
          • Jose Manuel Mandry
    • Georgia
      • Stockbridge, Georgia, United States, 30281
        • Recruiting
        • Clinical Research Atlanta
        • Principal Investigator:
          • Deon Miller
      • Union City, Georgia, United States, 30291
        • Recruiting
        • Rophe Adult and Pediatric Medicine/SKYCRNG
        • Principal Investigator:
          • Dwight Blake
        • Contact:
          • Phone Number: 470-317-3604
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Recruiting
        • Family First Medical Center
        • Contact:
          • Phone Number: 2085527700
        • Principal Investigator:
          • Flint Rudd Packer
    • Indiana
      • Muncie, Indiana, United States, 47304
        • Recruiting
        • American Health Network of IN, LLC
        • Principal Investigator:
          • Jonathan David Condit
    • Kansas
      • Wichita, Kansas, United States, 67218
        • Recruiting
        • Tekton Research - Wichita
        • Principal Investigator:
          • Brandon Alleman
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
        • Recruiting
        • Alliance for Multispecialty Research, LLC
        • Principal Investigator:
          • Robert J Noveck
    • Michigan
      • Dearborn, Michigan, United States, 48126
        • Recruiting
        • Revival Research Institute - Dearborn
        • Principal Investigator:
          • Abdulhassan Saad
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic
        • Contact:
          • Phone Number: 406-435-8470
        • Principal Investigator:
          • Lauren Kleess
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • Ellipsis Research Group
        • Contact:
          • Phone Number: 718-499-6099
        • Principal Investigator:
          • Jorge Serje
      • Manlius, New York, United States, 13104
        • Recruiting
        • Central New York Clinical Research
        • Contact:
          • Phone Number: 315-682-3263
        • Principal Investigator:
          • Jon Christopher Stringer
    • North Carolina
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Monroe Biomedical Research
        • Principal Investigator:
          • Awawu Igbinadolor
      • New Bern, North Carolina, United States, 28562
        • Recruiting
        • Lucas Research - New Bern
        • Contact:
          • Phone Number: 2522225700
        • Principal Investigator:
          • Claire Ann Presswood
    • Ohio
      • Dublin, Ohio, United States, 43016
        • Recruiting
        • Aventiv Research
        • Principal Investigator:
          • Henry Youga
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Recruiting
        • Intend Research, LLC
        • Contact:
          • Phone Number: 405-701-8999
        • Principal Investigator:
          • Lisa Connery
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • The Corvallis Clinic, P.C.
        • Principal Investigator:
          • Shannon Hopson
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15243
        • Recruiting
        • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair
        • Contact:
          • Phone Number: 412-942-0023
        • Principal Investigator:
          • Raman S Purighalla
      • Uniontown, Pennsylvania, United States, 15401
        • Recruiting
        • Preferred Primary Care Physicians
        • Contact:
          • Phone Number: 724-912-0033
        • Principal Investigator:
          • Paul A. Hartley
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • The Research Center of the Upstate
        • Contact:
          • Phone Number: 864-626-3117
        • Principal Investigator:
          • Harlicia Farley
      • Lancaster, South Carolina, United States, 29720
        • Recruiting
        • MDFirst Research, LLC
        • Principal Investigator:
          • AMRENDRA KUMAR
        • Contact:
          • Phone Number: 704-491-1102
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Recruiting
        • The Jackson Clinic
        • Contact:
          • Phone Number: 731-660-8396
        • Principal Investigator:
          • Kellie Wallace-Wilding
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Dallas Diabetes Research Center
        • Contact:
          • Phone Number: 972-566-7799
        • Principal Investigator:
          • Dan Lender
      • Houston, Texas, United States, 77040
        • Recruiting
        • Juno Research
        • Principal Investigator:
          • Damaris Vega
      • Houston, Texas, United States, 77089
        • Recruiting
        • Amir A Hassan, MD, PA
        • Contact:
          • Phone Number: 2819443610
        • Principal Investigator:
          • Amir Ali Hassan, MD
      • Houston, Texas, United States, 77079
        • Recruiting
        • Endocrine Ips, Pllc
        • Contact:
          • Phone Number: 713-973-3415
        • Principal Investigator:
          • Amer S Al-Karadsheh
    • Virginia
      • Burke, Virginia, United States, 22015
        • Recruiting
        • Burke Internal Medicine and Research
        • Contact:
          • Phone Number: 703-455-9711
        • Principal Investigator:
          • Nashwa Gabra

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have Type 2 Diabetes
  • Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
  • Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
  • Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
  • Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria:

  • Have Type 1 Diabetes
  • Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
  • Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
  • Have New York Heart Association functional classification IV congestive heart failure.
  • Have acute or chronic 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
Intervention / Treatment
Placebo Comparator: Placebo
Participants will receive placebo orally.
Drug: Placebo
Administered orally
Experimental: Orforglipron Dose 1
Participants will receive orforglipron orally.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970
Experimental: Orforglipron Dose 2
Participants will receive orforglipron orally.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970
Experimental: Orforglipron Dose 3
Participants will receive orforglipron orally.
Drug: Orforglipron
Administered orally.
Other Names:
  • LY3502970

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 40
Baseline, Week 40

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Achieved Weight Loss of ≥5%
Time Frame: Week 40
Week 40
Change from Baseline in Fasting Serum Glucose
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Body Weight
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol)
Time Frame: Week 40
Week 40
Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol)
Time Frame: Week 40
Week 40
Percentage Change from Baseline in Body Weight
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG)
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Non-HDL Cholesterol
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage Change from Baseline in Triglycerides
Time Frame: Baseline, Week 40
Baseline, Week 40

Collaborators and Investigators

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

Sponsor

Eli Lilly and Company

Investigators

  • 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.

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)

August 9, 2023

Primary Completion (Estimated)

April 9, 2025

Study Completion (Estimated)

April 9, 2025

Study Registration Dates

First Submitted

July 25, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

August 2, 2023

Study Record Updates

Last Update Posted (Actual)

April 16, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18564
  • J2A-MC-GZGT (Other Identifier: Eli Lilly and Company)
  • U1111-1290-5157 (Other Identifier: UTN Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant 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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