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

Sponsor
Eli Lilly and Company
Study ID
NCT07613307
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 31, 2026
Status verified
May 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
130 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Orforglipron
    Administered orally

Primary Outcome Measure

Change from Baseline in Hemoglobin A1C (HbA1c) [ Time Frame: Baseline, up to 8 Weeks after Start of Ramadan ]

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

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