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

ClinicalTrials.gov ID

NCT07613307

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 3

Enrollment

130Estimated

Last Update Posted

Sep 8, 2026Actual

Start Date

Jul 15, 2026Actual

Primary Completion Date

May 2027Estimated

Completion Date

May 2027Estimated

Official Title

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)

Brief Summary

The purpose of this study is to test the efficacy and safety of orforglipron in participants with T2D (type 2 diabetes) who participate in fasting during Ramadan. For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.

• Diabetes Mellitus, Type 2
• Diabetes Melletus
• Glucose Metabolism Disorders
• Metabolic Disorders
• Nutritional and Metabolic Diseases
• Endocrine System Diseases
• Feeding Behavior
• Behavior
• Fasting
• Glucagon-Like Peptide-1 Receptor
• Glucagon-Like Peptide Receptors
• Receptors, G-Protein-Coupled
• Receptors, Cell Surface
• Membrane Proteins
• Proteins
• Receptors, Peptide

• Orforglipron

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 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.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Eli Lilly and CompanyINDUSTRY

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