A Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor

JRCT ID: jRCT2031230504

Registered date:12/12/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 04/01/2024
• Target sample size: 520
• Countries of recruitment: Brazil,Japan,China,Japan,Puerto Rico,Japan,Romania,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 orally.
Intervention: Drug: Placebo

Outcome(s)

• Primary Outcome: Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ]

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]
Have been treated with stable doses of the same formulation of the following for >=90 days prior to screening visit 1 and have maintained the same doses through randomization:

insulin glargine U-100 (100 U/mL) >=0.20 U/kg/QD (units per kilogram per day) or >=15 U/QD alone, or
insulin glargine U-100 (100 U/mL)>=0.20 U/kg/QD or >=15 U/QD in combination with
metformin, or
SGLT-2 inhibitor.
Are of stable body weight (+-5%) for at least 90 days prior to screening visit 1 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 kg/m^2 at baseline.

Exclude criteria

Have New York Heart Association functional classification III-IV congestive heart failure.
Have had any of the following cardiovascular conditions within 60 days prior to baseline.

acute myocardial infarction
cerebrovascular accident (stroke), or
hospitalization for congestive heart failure.
Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease
Have had chronic or acute pancreatitis any time.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06109311