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Type 2 DiabetesPhase 3ACHIEVE-1NCT05971940

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

A Phase 3 study testing Orforglipron in people with Type 2 Diabetes, run by Eli Lilly and Company at 89 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes
What is being tested?
Orforglipron
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
559 participants
Where
89 sitesin 6 countries
Study dates
9 Aug 2023to 3 Apr 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

89 sites in 6 countries.

89 sites in 6 countries

United States41 sites

  • Billings Clinic

    Billings, Montana, 59101

  • Ellipsis Research Group - Brooklyn - 7th Street

    Brooklyn, New York, 11215

  • Burke Internal Medicine and Research

    Burke, Virginia, 22015

  • Invictus Clinical Research Group

    Coconut Creek, Florida, 33073

  • The Corvallis Clinic, P.C.

    Corvallis, Oregon, 97330

  • Connecticut Clinical Research - Cromwell

    Cromwell, Connecticut, 06416

  • Velocity Clinical Research, Dallas

    Dallas, Texas, 75230

  • Revival Research Institute

    Dearborn, Michigan, 48126

  • Hillcrest Medical Research

    DeLand, Florida, 32720

  • Centricity Research Dublin Multispecialty

    Dublin, Ohio, 43016

  • Neighborhood Healthcare Institute of Health

    Escondido, California, 92025

  • The Research Center of The Upstate

    Greenville, South Carolina, 29607

  • Juno Research

    Houston, Texas, 77040

  • Endocrine Ips, Pllc

    Houston, Texas, 77079

  • Amir A Hassan, MD, PA

    Houston, Texas, 77089

  • Velocity Clinical Research, Huntington Park

    Huntington Park, California, 90255

  • Family First Medical Center

    Idaho Falls, Idaho, 83404

  • The Jackson Clinic

    Jackson, Tennessee, 38305

  • MDFirst Research, LLC

    Lancaster, South Carolina, 29720

  • Ark Clinical Research

    Long Beach, California, 90815

  • Velocity Clinical Research, Westlake

    Los Angeles, California, 90057

  • K2 Medical Research

    Maitland, Florida, 32751

  • Central New York Clinical Research

    Manlius, New York, 13104

  • Global Health Research Center, Inc.

    Miami Lakes, Florida, 33016

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112

  • American Health Network of Indiana, LLC - Muncie

    Muncie, Indiana, 47304

  • Lucas Research - New Bern

    New Bern, North Carolina, 28562

  • Alliance for Multispecialty Research, LLC

    New Orleans, Louisiana, 70119

  • Infinity Clinical Research - Norco

    Norco, California, 92860

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069

  • West Orange Endocrinology

    Ocoee, Florida, 34761

  • Preferred Primary Care Physicians, Preferred Clinical Research-St. Clair

    Pittsburgh, Pennsylvania, 15243

  • Norcal Endocrinology & Internal Medicine

    San Ramon, California, 94583

  • Syed Research Consultants Llc

    Sheffield, Alabama, 35660

  • Clinical Research Atlanta

    Stockbridge, Georgia, 30281

  • Epic Medical Research - Surprise

    Surprise, Arizona, 85378

  • Quality of Life Medical & Research Center

    Tucson, Arizona, 85712

  • University Clinical Investigators, Inc.

    Tustin, California, 92780

  • Rophe Adult and Pediatric Medicine/SKYCRNG

    Union City, Georgia, 30291

  • Preferred Primary Care Physicians

    Uniontown, Pennsylvania, 15401

  • Tekton Research - Wichita

    Wichita, Kansas, 67218

Other trials in United States

China15 sites

  • Luhe Hospital

    Beijing, Beijing Municipality, 100000

  • Beijing Hospital

    Beijing, Beijing Municipality, 100730

  • Beijing Pinggu District Hospital

    Beijing, Beijing Municipality, 101200

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Shunde Hospital of Southern Medical Univesity

    Foshan, Guangdong, 528399

  • The Fourth Affiliated Hospital of Harbin Medical University

    Harbin, Heilongjiang, 150001

  • Huizhou Municipal Central Hospital

    Huizhou, Guangdong, 516001

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Nanjing First Hospital

    Nanjing, Jiangsu, 210006

  • The Second Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu, 210011

  • Nanyang First People's Hospital

    Nanyang, Henan, 473001

  • Pudong New Area People's Hospital Shanghai

    Shanghai, Shanghai Municipality, 201200

  • Wannan Medical College Yijishan Hospital

    Wuhu, Anhui, 241001

  • The Second Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450014

  • Affiliated Hospital of Jiangsu University

    Zhenjiang, Jiangsu, 212000

Other trials in China

Japan14 sites

  • Hayashi Diabetes Internal Medicine Clinic

    Chigasaki, Kanagawa, 253-0044

  • Hasegawa Medical Clinic

    Chitose, Hokkaido, 066-0032

  • The Institute of Medical Science, Asahi Life Foundation

    Chuo-ku, Tokyo, 103-0002

  • Tokyo-Eki Center-building Clinic

    Chuo-ku, Tokyo, 103-0027

  • Fukuwa Clinic

    Chuo-ku, Tokyo, 104-0031

  • Steel Memorial Yahata Hospital

    Kitakyushu, Fukuoka, 805-8508

  • Morinaga Ueno Clinic

    Kumamoto, 860-0863

  • Tokuyama Clinic

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

  • MinamiAkatsukaClinic

    Mito, Ibaraki, 311-4153

  • Abe Clinic

    Ōita, 870-0039

  • Heishinkai Medical Group ToCROM Clinic

    Shinjuku-ku, Tokyo, 160-0008

  • Medical Corporation Heishinkai OCROM Clinic

    Suita-shi, Osaka, 565-0853

  • Medical Corporation Yuga Tsuruma Kaneshiro Diabetes Clinic

    Yamato-shi, Kanagawa, 242-0004

  • Iwamoto Clinic

    Zentsujichó, Kagawa-ken, 765-0071

Other trials in Japan

India9 sites

  • M S Ramaiah Medical College and Hospitals

    Bangalore, Karnataka, 560054

  • Medstar Speciality Hospital

    Bangalore, Karnataka, 560092

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • Kumudini Devi Diabetes Research Center

    Hyderabad, Telangana, 500072

  • Institute of Post Graduate Medical Education and Research and Seth Sukhlal Karnani Memorial Hospital

    Kolkata, West Bengal, 700020

  • BSES MG Hospital

    Mumbai, Maharashtra, 400058

  • All India Institute of Medical Sciences (AIIMS) - Nagpur

    Nagpur, Maharashtra, 441108

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • GMERS Medical College and General Hospital

    Vadodara, Gujarat, 390021

Other trials in India

Mexico8 sites

  • Investigacion En Salud Y Metabolismo S.C / Nutricion Clinica / Unidad de Base de Datos

    Chihuahua City, 31110

  • Unidad de Investigaci�n Cl�nica Cardiometabolica de Occidente

    Guadalajara, Jalisco, 44150

  • Centro de Investigacion Medica Integral

    Guadalajara, Jalisco, 44160

  • Salud Cardiovascular

    Guadalajara, Jalisco, 44860

  • PanAmerican Clinical Research - Querétaro - Avenida Antea

    Querétaro, 76100

  • Instituto Veracruzano en Investigación Clínica S.C.

    Veracruz, 91851

  • FAICIC S. de R.L. de C.V.

    Veracruz, 91900

  • Centro de Investigacion Medica de Occidente, S.C.

    Zapopan, Jalisco, 44260

Other trials in Mexico

Puerto Rico2 sites

  • Puerto Rico Health Institute

    Dorado, 00646

  • Advance Medical Research Center

    San Juan, 00926

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Type 2 Diabetes
Being tested
Orforglipron, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OrforglipronDrug

    Also called LY3502970

    Administered orally

  • PlaceboDrug

    Administered orally

Study groups in NCT05971940
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants received once daily (QD) doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
Receives: Drug: Placebo
3 mg OrforglipronExperimentalParticipants received orforglipron capsules administered orally QD, starting at 1 milligram (mg) and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
Receives: Drug: Orforglipron
12 mg OrforglipronExperimentalParticipants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
Receives: Drug: Orforglipron
36 mg OrforglipronExperimentalParticipants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
Receives: Drug: Orforglipron

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in HbA1c

    • 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) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ [less than or equal to] 8.0%, > [greater than] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 40

Secondary outcomes (11)

  1. Percentage of Participants With an HbA1c Target Value of < 7.0% (53 mmol/Mol)

    Percentage of participants with an HbA1c target value of less than (<) 7.0% (53 millimoles per mole [mmol/mol]) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no).

    Measured: Week 40

  2. Percentage of Participants With an HbA1c Target Value of ≤6.5% (48 mmol/Mol)

    Percentage of Participants with an HbA1c target value of less than or equal to (≤) 6.5% (48 mmol/mol) was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no).

    Measured: Week 40

  3. Change From Baseline in Fasting Serum Glucose (FSG)

    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) with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤ [less than or equal to] 8.0%, > [greater than] 8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 40

  4. Percent Change From Baseline in Body Weight

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 40

  5. Change From Baseline in Body Weight

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 40

  6. Percent Change From Baseline in Non-High-Density Lipoprotein (Non-HDL) Cholesterol

    Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 40

  7. Percent Change From Baseline in Triglycerides

    Values represented under "Geometric LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis : log (Actual Measurement/Baseline) = country, treatment by time, log(baseline) by time by treatment, and strata by time by treatment in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 40

  8. Change From Baseline in Daily Average 7-Point Self-Monitored Blood Glucose (SMBG)

    The self-monitored plasma glucose (SMBG) data were collected at the following 7 time points: Morning Premeal - Fasting, Morning 2-hour Post meal, Midday Premeal, Midday 2-hour Post meal, Evening Premeal, Evening 2-hour Post meal and Bedtime. The daily average was calculated as the average of the 7 blood glucose values collected on a particular day. Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 40

  9. Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction

    Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression with analysis country, treatment by baseline and treatment by strata in the model. Strata were defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no).

    Measured: Week 40

  10. Change From Baseline in Systolic Blood Pressure (SBP)

    Values represented under "LS Mean" are model-based estimates (MBE) of the unconditional average treatment effect. MBE was calculated using a MMRM with analysis country, treatment by time, baseline by time by treatment, and strata by time by treatment in the model. Strata was defined by joint levels of baseline HbA1c (≤8.0%, >8.0%) and prior use of any antihyperglycemic medication (yes or no). Variance-covariance structure for change from baseline was unstructured.

    Measured: Baseline, Week 40

  11. Change From Baseline in Short Form-36 Health Survey Version 2 (SF-36v2) Acute Form (Physical-Component and Mental-Component) Scores

    The SF-36v2 is a participant-reported measure designed to assess health status using 36 items across 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The physical functioning domain assesses limitations due to health "now," whereas the remaining domains assess functioning "in the past week." Each domain is scored individually, and information from these 8 domains is aggregated into 2 health component summary scores, the Physical Component Summary and Mental Component Summary. Items are answered on Likert scales of varying lengths (3-point, 5-point, or 6-point scales). Scoring of each domain and both summary scores are norm based and presented in the form of T-scores, with a mean of 50 and a standard deviation of 10. Higher scores indicate better levels of function and/or better health. Range cannot be specified in norm-based scores.

    Measured: Baseline, Week 40

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2023
  2. Study start9 Aug 2023
  3. Primary completion3 Apr 2025
  4. Study completion3 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
559 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05971940
Sponsor's protocol ID
18564
Other IDs
J2A-MC-GZGT, U1111-1290-5157
Acronym
ACHIEVE-1
Status last verified
Aug 2026
First submitted
25 Jul 2023
Last updated
3 Sep 2026
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Rosenstock J, Hsia S, Nevarez Ruiz L, Eyde S, Cox D, Wu WS, Liu R, Li J, Fernandez Lando L, Denning M, Ludwig L, Chen Y; ACHIEVE-1 Trial Investigators. Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist, in Early Type 2 Diabetes. N Engl J Med. 2025 Sep 18;393(11):1065-1076. doi: 10.1056/NEJMoa2505669. Epub 2025 Jun 21.

    PubMed 40544435

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Orforglipron in people with Type 2 Diabetes, run by Eli Lilly and Company at 89 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 89 sites in United States, China, Japan, India, Mexico and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in HbA1c (time frame: Baseline, Week 40). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05971940, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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