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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 statusNot yet recruiting
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

This trial is not recruiting at the moment. You can still explore other options: