ACHIEVE-RAM

Not yet recruitingPhase 3

A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes Who Observe Ramadan Fasting

A Phase 3b, Multicenter, Multi-Country, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of Orforglipron in Adult Participants With Type 2 Diabetes Who Observe Ramadan Fasting (ACHIEVE-RAM)

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

130

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•Hemoglobin A1C (HbA1c)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07613307

Org study ID27746

Secondary IDJ2A-MC-GZPVEli Lilly and Company

Timeline

Milestones

Study first posted2026-05-29actual

Last update posted2026-05-29actual

Study start2026-05estimated (month precision)

Primary completion2027-05estimated (month precision)

Study completion2027-05estimated (month precision)

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards.

•Have an HbA1c value of at least 7.0% (53 millimoles per mole (mmol/mol)) to less than 9.5% (91 mmol/mol) at screening.

•Intend to be compliant with the fast during the Ramadan period.

•Have had stable body weight self-reported change of 5 kilograms (kg) or lower during the 90 days prior to screening.

•Have body mass index (BMI) of 25 kilograms per meter square (kg/m2) or higher at screening.

Exclusion criteria

•Have any form of diabetes other than T2D, including type 1 diabetes (T1D), gestational diabetes, latent autoimmune diabetes, maturity-onset diabetes of the young, and medication-induced diabetes

•Have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.

•Have a history of chronic or acute pancreatitis any time prior to screening

•Have evidence of a significant, uncontrolled endocrine abnormality, for example, thyrotoxic or adrenal crises, in the opinion of the investigator

•Have a family (first-degree relative) or personal history of medullary thyroid carcinoma

•Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.

•Have a history of cholecystectomy (surgically removed gallbladder)

•Have New York Heart Association Functional Classification IV congestive heart-failure.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes

Weight & body composition

Patient-reported / QoL

Weight & body composition

2 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Up to 8 Weeks after Start of Ramadan

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change in Body Weight

Time frame:4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]

percent change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Change from Baseline in Hemoglobin A1C (HbA1c)

Time frame:Baseline, up to 8 Weeks after Start of Ramadan

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants with an HbA1c of less than (<) 7 Percent (%) (53 millimeters per mole (mmol/mol))

Time frame:Baseline, Up to 8 Weeks after Start of Ramadan

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Up to 8 Weeks after Start of Ramadan

change from baseline, improvement

Secondary/protocol endpoint

Percent Change in HbA1c

Time frame:4 Weeks Prior to Ramadan, Up to Week 8 after Start of Ramadan]

percent change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Change in EuroQol 5-Dimension 5-Level (EQ-5D-5L) Index

Time frame:Baseline, Up to 8 Weeks after Start of Ramadan

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.