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A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral LY3502970 Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (J2A-MC-GZGT)

A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (J2A-MC-GZGT)

Masaki Takeshi

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120023812

LTG_CallCenter@lists.lilly.com

Not Recruiting

Oct. 04, 2023

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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 naive 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.

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 hepatitis

Both

Type 2 Diabetes

Drug: Orforglipron
Administered orally.
Other Name: LY3502970
Drug: Placebo
Administered orally

Study Arms
Experimental: Orforglipron Dose 1
Participants will receive orforglipron orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 2
Participants will receive orforglipron orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 3
Participants will receive orforglipron orally.
Intervention: Drug: Orforglipron
Placebo Comparator: Placebo
Participants will receive placebo.
Intervention: Drug: Placebo

Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Week 40 ]

+81-42-701-1041

July. 10, 2023

Yes

Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

China/India/Mexico/Puerto Rico/United States