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

JRCT ID: jRCT2031230325

Registered date:05/09/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 04/10/2023
• Target sample size: 520
• Countries of recruitment: China,Japan,India,Japan,Mexico,Japan,Puerto Rico,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

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

Outcome(s)

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 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.

Exclude 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 hepatitis

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT05971940