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

JRCT ID: jRCT2031230337

Registered date:09/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 28/09/2023
• Target sample size: 399
• Study type: Interventional

Intervention(s)

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

Outcome(s)

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

Key inclusion & exclusion criteria

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

Include criteria

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.

Exclude criteria

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

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06010004