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

Plain-language guide to NCT07613307: phase 3 interventional trial of Orforglipron (Foundayo, non-peptide), 130 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07613307
Phase
phase 3
Status
recruiting participants
Start
2026-07-15
Completion (planned or actual)
2027-05
Participants
130 (estimated)
Design
na, open label (everyone knows who gets what), treatment
Conditions studied
Diabetes Mellitus, Type 2; Diabetes Melletus; Glucose Metabolism Disorders; Metabolic Disorders; Nutritional and Metabolic Diseases; Endocrine System Diseases
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 3 trial tested Orforglipron (Foundayo, non-peptide).

For each participant, the study will last up to 48 weeks with a minimum of 7 in clinic visits and 4 virtual visits.

It had 1 arm (groups): Orforglipron (experimental).

Administered orally.

The registry classes the interventions as drug.

Who Took Part

The registry lists 130 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Have a clinical diagnosis of T2D based on the World Health Organization (WHO) classification or other locally applicable diagnostic standards. 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.

The full record lists 5 inclusion and 7 exclusion criteria; among the exclusions: 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 a history of cholecystectomy (surgically removed gallbladder).

How the Study Was Run

The set-up was single-group and open-label.

Nothing was hidden in this open-label Orforglipron (Foundayo, non-peptide) study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-07-15 with completion listed for 2027-05.

It ran at 40 sites in South Africa (14), Saudi Arabia (10), India (9) and United Arab Emirates (7).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from Baseline in Hemoglobin A1C (HbA1c) (time frame: Baseline, up to 8 Weeks after Start of Ramadan).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Orforglipron (Foundayo, non-peptide) in 130 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Orforglipron (Foundayo, non-peptide) compound page, all human trials.

Our Notes on the Compound

Orforglipron (Foundayo, non-peptide): An oral small-molecule GLP-1 receptor agonist (not a peptide); FDA-approved as Foundayo on April 1, 2026 for chronic weight management.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.