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A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J) (J2A-JE-GZPE)

A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes (J2A-JE-GZPE)

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

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Not Recruiting

Sept. 05, 2023

Interventional

randomized controlled trial

open(masking not used)

dose comparison control

parallel assignment

treatment purpose

Have Type 2 Diabetes (T2D)
Have HbA1c >=7.0% (>=53 mmol/mol) to <=10.5% (<=91 mmol/mol) as determined by the central laboratory at screening.
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 BMI >=23.0 kilogram/square meter (kg/m2) at screening.

Have Type 1 Diabetes (T1D).
Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
Have New York Heart Association functional classification IV congestive heart failure.
Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.

acute myocardial infarction
cerebrovascular accident (stroke), or
hospitalization for congestive heart failure
Have acute or chronic hepatitis and pancreatitis

Both

Type 2 Diabetes

Drug: Orforglipron
Administered orally
Other Name: LY3502970

<Study Arms>
Experimental: Orforglipron Dose 1
Participants will receive orforglipron administered orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 2
Participants will receive orforglipron administered orally.
Intervention: Drug: Orforglipron
Experimental: Orforglipron Dose 3
Participants will receive orforglipron administered orally.
Intervention: Drug: Orforglipron

Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 52 ]

+81-42-648-5551

Aug. 03, 2023

Yes

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

none