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

NCT06109311 | Completed Phase 3 FDA Drug

• 4 other identifiers: 18567J2A-MC-GZGWU1111-1294-27972023-507280-18-00
• Study Type: interventional
• Target: 546
• Locations: 6 countries
• Sites: 70

Brief Summary

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.

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c)

  Baseline, Week 40

Secondary Outcomes (14)

• Orforglipron Dose 3: Change from Baseline in HbA1c

  Baseline, Week 40

• Percentage of Participants Who Achieved HbA1c <7.0% (53 millimoles per mole (mmol/mol))

  Baseline to Week 40

• Percentage of Participants Who Achieved HbA1c ≤6.5% (48 mmol/mol)

  Baseline to Week 40

• Change from Baseline in Fasting Serum Glucose

  Baseline, Week 40

• Percentage Change from Baseline in Body Weight

  Baseline, Week 40

Study Arms (4)

Orforglipron Dose 1

EXPERIMENTAL

Participants will receive orforglipron orally.

Drug: Orforglipron

Orforglipron Dose 2

EXPERIMENTAL

Participants will receive orforglipron orally.

Drug: Orforglipron

Orforglipron Dose 3

EXPERIMENTAL

Participants will receive orforglipron orally.

Drug: Orforglipron

Placebo

PLACEBO COMPARATOR

Participants will receive placebo orally.

Drug: Placebo

Interventions

Orforglipron DRUG

Administered orally.

Also known as: LY3502970

Orforglipron Dose 1; Orforglipron Dose 2; Orforglipron Dose 3

Placebo DRUG

Administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (70)

MD First Research - Chandler

Chandler, Arizona, 85286, United States

Location

Phoenix Clinical LLC

Phoenix, Arizona, 85014, United States

Location

SanRo Clinical Research Group

Bryant, Arkansas, 72022, United States

Location

Velocity Clinical Research, Gardena

Gardena, California, 90247, United States

Location

Loma Linda University Health System

Loma Linda, California, 92350, United States

Location

Western University of Health Sciences

Pomona, California, 91766, United States

Location

Med Partners, Inc. dba Premiere Medical Center of Burbank, Inc.

Toluca Lake, California, 91602, United States

Location

CMR of Greater New Haven, LLC

Hamden, Connecticut, 06517, United States

Location

Care Access - Brandon

Brandon, Florida, 33510, United States

Location

Encore Medical Research

Hollywood, Florida, 33024, United States

Location

Encore Medical Research - Weston

Weston, Florida, 33331, United States

Location

Orita Clinical Research

Decatur, Georgia, 30034, United States

Location

Bingham Memorial Hospital

Blackfoot, Idaho, 83221, United States

Location

St. Luke's Humphreys Diabetes Center: Boise

Boise, Idaho, 83702, United States

Location

Cotton O'Neil Diabetes & Endocrinology

Topeka, Kansas, 66606, United States

Location

The Research Group of Lexington

Lexington, Kentucky, 40503, United States

Location

Clinvest Headlands Llc

Springfield, Missouri, 65807, United States

Location

Richmond University Medical Center

Staten Island, New York, 10310, United States

Location

Velocity Clinical Research, Mt. Auburn

Cincinnati, Ohio, 45219, United States

Location

Velocity Clinical Research, Medford

Medford, Oregon, 97504, United States

Location

Tristar Clinical Investigations

Philadelphia, Pennsylvania, 19114, United States

Location

Frontier Clinical Research, LLC

Scottdale, Pennsylvania, 15683, United States

Location

Lifedoc Research - Lenox Park Drive

Memphis, Tennessee, 38115, United States

Location

Consano Clinical Research, LLC

Shavano Park, Texas, 78231, United States

Location

Texas Valley Clinical Research

Weslaco, Texas, 78596, United States

Location

CEDOES

Vitória, Espírito Santo, 29055450, Brazil

Location

L2IP - Instituto de Pesquisas Clínicas

Brasília, Federal District, 70200730, Brazil

Location

Quanta Diagnóstico e Terapia

Curitiba, Paraná, 80040-110, Brazil

Location

Insight Centro de Pesquisas

Porto Alegre, Rio Grande do Sul, 90560-003, Brazil

Location

Centro de Pesquisa Sao Lucas

Campinas, São Paulo, 13060-803, Brazil

Location

Centro Multidisciplinar de Estudos Clinicos

São Bernardo do Campo, São Paulo, 09715-090, Brazil

Location

ISPEM - Instituto São José dos Campos em Pesquisas Médicas

São José dos Campos, São Paulo, 12243-280, Brazil

Location

IBPClin - Instituto Brasil de Pesquisa Clínica

Rio de Janeiro, 20241-180, Brazil

Location

CPQuali Pesquisa Clínica

São Paulo, 01228-000, Brazil

Location

The Second People's Hospital of Hefei

Hefei, Anhui, 230011, China

Location

Wannan Medical College Yijishan Hospital

Wuhu, Anhui, 241001, China

Location

Beijing Hospital

Beijing, Beijing Municipality, 100051, China

Location

Chongqing General Hospital

Chongqing, Chongqing Municipality, 401147, China

Location

The First Affiliated Hospital of Henan University of Science &Technology

Luoyang Shi, Henan, 471003, China

Location

The Second Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450014, China

Location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Location

Nanjing First Hospital

Nanjing, Jiangsu, 210012, China

Location

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212000, China

Location

Jinan Central Hospital

Jinan, Shandong, 250013, China

Location

Tokuyama Clinic

Mihama-ku,Chiba City, Chiba, 261-0004, Japan

Location

Hasegawa Medical Clinic

Chitose, Hokkaido, 066-0032, Japan

Location

MinamiAkatsukaClinic

Mito, Ibaraki, 311-4153, Japan

Location

Matoba Internal Medicine Clinic

Ebina, Kanagawa, 243-0432, Japan

Location

Takai Internal Medicine Clinic

Kamakura-shi, Kanagawa, 247-0056, Japan

Location

Shiraiwa Medical Clinic

Kashihara, Osaka, 582-0005, Japan

Location

The Institute of Medical Science, Asahi Life Foundation

Chuo-ku, Tokyo, 103-0002, Japan

Location

Tokyo-Eki Center-building Clinic

Chuo-ku, Tokyo, 103-0027, Japan

Location

Fukuwa Clinic

Chuo-ku, Tokyo, 104-0031, Japan

Location

Medical Corporation Sato Medical clinic

Ootaku, Tokyo, 143-0015, Japan

Location

Tama Center Clinic Mirai

Tama, Tokyo, 206-0633, Japan

Location

Jinnouchi Hospital

Kumamoto, 862-0976, Japan

Location

Kansai Electric Power Hospital

Osaka, 553-0003, Japan

Location

Abe Clinic

Ōita, 870-0039, Japan

Location

Centro de Endocrinologia y Nutricion

Caguas, 00725, Puerto Rico

Location

FDI Clinical Research

San Juan, 00927, Puerto Rico

Location

Diabdana

Oradea, Bihor County, 410147, Romania

Location

C.M.D.T.A. Neomed

Brasov, Brașov County, 500283, Romania

Location

Geea Medical Easy Diet

Bucharest, București, 010627, Romania

Location

Centrul Medical NutriLife

Bucharest, București, 013764, Romania

Location

Centrul Medical Endocrinologie si Diabet Dr. Paveliu

Bucharest, București, 50538, Romania

Location

CMI DNBM Dr. Pop Lavinia

Baia Mare, Maramureş, 430222, Romania

Location

SC Dentosim Queen SRL - Centrul Medical Diamed

Târgu Mureş, Mureș County, 540098, Romania

Location

Milena Sante

Galați, 800001, Romania

Location

Diamed Obesity

Galați, 800291, Romania

Location

Clinica Korall

Satu Mare, 440055, Romania

Location

Related Links

• 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)

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

orforglipron

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2023
• First Posted: October 31, 2023
• Study Start: November 10, 2023
• Primary Completion: September 15, 2025
• Study Completion: September 15, 2025
• Last Updated: October 20, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

PR (2); BR (9); CN (10); JP (14); RO (10); US (25)