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Purpose

The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Have Type 2 Diabetes - Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening. - Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization. - Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment. - Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.

Exclusion Criteria

  • Have Type 1 Diabetes - Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization. - Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema - Have New York Heart Association functional classification IV congestive heart failure. - Have acute or chronic pancreatitis

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Orforglipron Dose 1 		Participants will receive orforglipron orally.
  • Drug: Orforglipron
    Administered orally.
    Other names:
    • LY3502970
Experimental
Orforglipron Dose 2 		Participants will receive orforglipron orally.
  • Drug: Orforglipron
    Administered orally.
    Other names:
    • LY3502970
Experimental
Orforglipron Dose 3 		Participants will receive orforglipron orally.
  • Drug: Orforglipron
    Administered orally.
    Other names:
    • LY3502970
Placebo Comparator
Placebo 		Participants will receive placebo orally.
  • Drug: Placebo
    Administered orally

Recruiting Locations

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
ClinicalTrials.gov@lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.