A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor (ACHIEVE-5)

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 Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.

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

  • Brazil
      • Rio de Janeiro, Brazil, 20241-180
        • Recruiting
        • IBPClin - Instituto Brasil de Pesquisa Clínica
        • Principal Investigator:
          • JOSELITA FRANÇA DE SIQUEIRA BODART
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 70200730
        • Recruiting
        • L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192
        • Principal Investigator:
          • Eduardo Freire Vasconcellos
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29055450
        • Recruiting
        • CEDOES
        • Principal Investigator:
          • queulla garret santos
    • Paraná
      • Curitiba, Paraná, Brazil, 80040-110
        • Recruiting
        • Pesquisa Clínica em Diabetes - Dra Rosângela Réa
        • Principal Investigator:
          • Rosangela Rea
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90560-003
        • Recruiting
        • Insight Centro de Pesquisas
        • Principal Investigator:
          • Cassiane Bonato
    • São Paulo
      • Sao Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Recruiting
        • Centro Multidisciplinar de Estudos Clinicos
        • Principal Investigator:
          • Claudia de Brito
  • China
    • Anhui
      • Hefei, Anhui, China, 230011
        • Recruiting
        • The Second People's Hospital of Hefei
        • Principal Investigator:
          • Jun Ye
      • Wuhu, Anhui, China, 241001
        • Recruiting
        • Wannan Medical College Yijishan Hospital
        • Principal Investigator:
          • Jialin Gao
    • Beijing
      • Beijing, Beijing, China, 100051
        • Recruiting
        • Beijing Hospital
        • Principal Investigator:
          • Lixin Guo
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Recruiting
        • Chongqing General Hospital
        • Principal Investigator:
          • Hongman Wang
    • Henan
      • Luoyang Shi, Henan, China, 471003
        • Recruiting
        • The First Affiliated Hospital of Henan University of Science &Technology
        • Principal Investigator:
          • Hongwei Jiang
      • Zhengzhou, Henan, China, 450014
        • Recruiting
        • The Second Affiliated Hospital of Zhengzhou University
        • Principal Investigator:
          • Qingju Li
    • Jiangsu
      • Nanjing, Jiangsu, China, 210011
        • Recruiting
        • The Second Affiliated Hospital of Nanjing Medical University
        • Principal Investigator:
          • Yibing Lu
      • Nanjing, Jiangsu, China, 210012
        • Recruiting
        • Nanjing First Hospital
        • Principal Investigator:
          • Jianhua Ma
      • Zhenjiang, Jiangsu, China, 212000
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Principal Investigator:
          • Guoyue Yuan
    • Shandong
      • Jinan, Shandong, China, 250013
        • Recruiting
        • Jinan Central Hospital
        • Principal Investigator:
          • Xiaolin Dong
  • Japan
      • Oita, Japan, 870-0039
        • Recruiting
        • Abe Clinic
        • Principal Investigator:
          • Katsushige Abe
      • Osaka, Japan, 553-0003
        • Recruiting
        • Kansai Electric Power Hospital
        • Principal Investigator:
          • Yoshiyuki Hamamoto
    • Chiba
      • Mihama-ku,Chiba City, Chiba, Japan, 261-0004
        • Recruiting
        • Tokuyama clinic
        • Principal Investigator:
          • Takahiko Tokuyama
    • Hokkaido
      • Chitose, Hokkaido, Japan, 066-0032
        • Recruiting
        • Hasegawa Medical Clinic
        • Principal Investigator:
          • Atsushi Hasegawa
    • Ibaraki
      • Mito, Ibaraki, Japan, 311-4153
        • Recruiting
        • MinamiAkatsukaClinic
        • Principal Investigator:
          • Hideo Takahashi
    • Kanagawa
      • Ebina, Kanagawa, Japan, 243-0432
        • Recruiting
        • Matoba Internal Medicine Clinic
        • Principal Investigator:
          • Kiyokazu Matoba
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Recruiting
        • Takai Internal Medicine Clinic
        • Principal Investigator:
          • Masahiko Takai
    • Osaka
      • Kashiwara, Osaka, Japan, 582-0005
        • Recruiting
        • Shiraiwa Medical Clinic
        • Principal Investigator:
          • Toshihiko Shiraiwa
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 104-0031
        • Recruiting
        • Fukuwa Clinic
        • Principal Investigator:
          • Yasushi Fukushima
      • Chuo-ku, Tokyo, Japan, 103-0002
        • Recruiting
        • The Institute for Adult Disease, Asahi Life Foundation
        • Principal Investigator:
          • Yukiko Onishi
      • Ootaku, Tokyo, Japan, 143-0015
        • Recruiting
        • Medical Corporation Sato Medical clinic
        • Principal Investigator:
          • Nobuyuki Sato
      • Tama, Tokyo, Japan, 206-0633
        • Recruiting
        • Tama Center Clinic Mirai
        • Principal Investigator:
          • Hitomi Fujii
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Recruiting
        • Centro de Endocrinologia y Nutricion
        • Principal Investigator:
          • Juan R Otero-Martinez
      • San Juan, Puerto Rico, 00927
        • Recruiting
        • FDI Clinical Research
        • Principal Investigator:
          • Oscar Ruiz Bermudez
  • Romania
      • Galați, Romania, 800001
        • Recruiting
        • Milena Sante
        • Principal Investigator:
          • Cristina-Victoria Mistodie
      • Galați, Romania, 800291
        • Recruiting
        • Diamed Obesity
        • Principal Investigator:
          • Magdalena Morosanu
      • Satu Mare, Romania, 440055
        • Recruiting
        • Clinica Korall
        • Principal Investigator:
          • Adriana Filimon
    • Bihor
      • Oradea, Bihor, Romania, 410147
        • Recruiting
        • Diabdana
        • Principal Investigator:
          • Dana Cosma
    • Brașov
      • Brasov, Brașov, Romania, 500283
        • Recruiting
        • C.M.D.T.A. Neomed
        • Principal Investigator:
          • Valentina Neacsu
    • Bucuresti
      • Bucharest, Bucuresti, Romania, 013764
        • Recruiting
        • Centrul Medical NutriLife
        • Principal Investigator:
          • Marlena Pascu
    • București
      • Bucharest, București, Romania, 010627
        • Recruiting
        • Geea Medical Easy Diet
        • Principal Investigator:
          • Georgeta Vacaru
      • Bucharest, București, Romania, 50538
        • Recruiting
        • Centrul Medical Endocrinologie si Diabet Dr. Paveliu
        • Principal Investigator:
          • Fraga Paveliu
    • Maramureș
      • Baia Mare, Maramureș, Romania, 430222
        • Recruiting
        • CMI DNBM Dr. Pop Lavinia
        • Principal Investigator:
          • Lavinia Pop
    • Mureș
      • Târgu Mureș, Mureș, Romania, 540098
        • Recruiting
        • SC Dentosim Queen SRL - Centrul Medical Diamed
        • Principal Investigator:
          • Daniela Ciomos
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85286
        • Recruiting
        • MD First Research - Chandler
        • Principal Investigator:
          • Rajiv Parikh
      • Phoenix, Arizona, United States, 85014
        • Recruiting
        • Phoenix Clinical LLC
        • Principal Investigator:
          • Brock Adam Merritt
    • Arkansas
      • Bryant, Arkansas, United States, 72022
        • Recruiting
        • SanRo Clinical Research Group
        • Principal Investigator:
          • Mark Albey
    • California
      • Loma Linda, California, United States, 92350
        • Recruiting
        • Loma Linda University Health System
        • Principal Investigator:
          • Warren Peters
      • Pomona, California, United States, 91766
        • Recruiting
        • Western University of Health Sciences
        • Principal Investigator:
          • Airani Sathananthan
      • Toluca Lake, California, United States, 91602
        • Recruiting
        • Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.
        • Principal Investigator:
          • Michael Marsh
    • Connecticut
      • Hamden, Connecticut, United States, 06517
        • Recruiting
        • CMR of Greater New Haven
        • Principal Investigator:
          • Joseph Soufer
    • Florida
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Encore Medical Research
        • Principal Investigator:
          • Rodolfo A. Perez
      • Weston, Florida, United States, 33331
        • Recruiting
        • Encore Medical Research - Weston
        • Principal Investigator:
          • Sandro Bacchelli
    • Georgia
      • Decatur, Georgia, United States, 30034
        • Recruiting
        • Orita Clinical Research
        • Principal Investigator:
          • Ahmad Jingo
    • Idaho
      • Blackfoot, Idaho, United States, 83221
        • Recruiting
        • Bingham Memorial Hospital
        • Principal Investigator:
          • Gary M Ullery
      • Boise, Idaho, United States, 83702
        • Recruiting
        • Humphreys Diabetes Center
        • Principal Investigator:
          • Sherwin C D'Souza
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Recruiting
        • Cotton O'Neil Clinical Research Center
        • Principal Investigator:
          • susan brian
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • The Research Group of Lexington
        • Principal Investigator:
          • Justin Arambasick
    • New York
      • Staten Island, New York, United States, 10310
        • Recruiting
        • Richmond University Medical Center
        • Principal Investigator:
          • Philip Otterbeck
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • Velocity Clinical Research, Mt. Auburn
        • Principal Investigator:
          • Matthew Wenker
    • Pennsylvania
      • Scottdale, Pennsylvania, United States, 15683
        • Recruiting
        • Frontier Clinical Research, LLC
        • Principal Investigator:
          • Tiffany Michael Pluto
    • Tennessee
      • Memphis, Tennessee, United States, 38115
        • Recruiting
        • Lifedoc Research - Lenox Park Drive
        • Principal Investigator:
          • Pedro Alejandro Velasquez-Mieyer
    • Texas
      • Shavano Park, Texas, United States, 78231
        • Recruiting
        • Consano Clinical Research, LLC
        • Principal Investigator:
          • Michelle Welch
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Texas Valley Clinical Research
        • Principal Investigator:
          • Eduardo Dusty Luna

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 (T2D)
  • Have HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]

  • Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:

    • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD (units per kilogram per day) or ≥20 U/QD alone, or
    • insulin glargine U-100 (100 U/mL) ≥0.25 U/kg/QD or ≥20 U/QD in combination with
    • metformin, or
    • SGLT-2 inhibitor, or
    • both metformin and SGLT-2 inhibitor.
  • Are of stable body weight (±5%) for at least 90 days prior to screening visit 1 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 kg/m^2 at baseline.

Exclusion Criteria:

  • Have New York Heart Association functional classification III-IV congestive heart failure.

  • Have had any of the following cardiovascular conditions within 60 days prior to baseline.

    • acute myocardial infarction
    • cerebrovascular accident (stroke), or
    • hospitalization for congestive heart failure.
  • Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
  • Have had chronic or acute pancreatitis any time.

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
Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)
Time Frame: Baseline, Week 40
Baseline, Week 40

Secondary Outcome Measures

Outcome Measure
Time Frame
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 Change from Baseline in Body Weight
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage Change from Baseline in Triglycerides
Time Frame: Baseline, Week 40
Baseline, Week 40
Orforglipron Dose 3: Change from Baseline in HbA1c
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol))
Time Frame: Baseline to Week 40
Baseline to Week 40
Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)
Time Frame: Baseline to Week 40
Baseline to Week 40
Percentage Change from Baseline in non-HDL (non-high-density lipoprotein) Cholesterol
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Systolic Blood Pressure
Time Frame: Baseline, Week 40
Baseline, Week 40
Change from Baseline in Daily Insulin Glargine Dose
Time Frame: Baseline, Week 40
Baseline, Week 40
Percentage of Participants Who Achieved Weight Loss of ≥5%
Time Frame: Baseline to Week 40
Baseline to Week 40
Percentage of Participants Who Achieved Weight Loss of ≥10%
Time Frame: Baseline to Week 40
Baseline to Week 40
Percentage of Participants Who Achieved Weight Loss of ≥15% from Baseline
Time Frame: Baseline to Week 40
Baseline to Week 40
Change from Baseline in Short Form 36-Version 2 (SF-36v2) Acute Form Domain and Summary Scores
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)

November 10, 2023

Primary Completion (Estimated)

June 25, 2025

Study Completion (Estimated)

June 25, 2025

Study Registration Dates

First Submitted

October 26, 2023

First Submitted That Met QC Criteria

October 26, 2023

First Posted (Actual)

October 31, 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

  • 18567
  • J2A-MC-GZGW (Other Identifier: Eli Lilly and Company)
  • U1111-1294-2797 (Other Identifier: UTN Number)
  • 2023-507280-18-00 (Other Identifier: EU Trial 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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