Health Trials

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

ConditionsDiabetes Mellitus, Type 2Diabetes MelletusGlucose Metabolism DisordersMetabolic DisordersNutritional and Metabolic DiseasesEndocrine System DiseasesFeeding BehaviorBehaviorFastingGlucagon-Like Peptide-1 ReceptorGlucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsReceptors, Peptide
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Orforglipron

    Drug

    Administered orally

Treatment groups

130 Participants
are divided into 1 treatment group
Group A: OrforglipronExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Hemoglobin A1C (HbA1c)

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

Secondary outcomes

1

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
2

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame
Baseline, Up to 8 Weeks after Start of Ramadan
3

Percent Change from Baseline in Body Weight

Time frame
Baseline, Up to 8 Weeks after Start of Ramadan
4

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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