A Study of Orforglipron (LY3502970) Compared With Semaglutide in Participants With Type 2 Diabetes Inadequately Controlled With Metformin

JRCT ID: jRCT2041230086

Registered date:04/10/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Type 2 Diabetes
• Date of first enrollment: 24/11/2023
• Target sample size: 1576
• Countries of recruitment: Argentina,Japan,China,Japan,Mexico,Japan,Puerto Rico,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: Orforglipron
Administered orally
Other Name: LY3502970
Drug: Semaglutide
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
Active Comparator: Semaglutide Dose 1
Participants will receive semaglutide orally.
Intervention: Drug: Semaglutide
Active Comparator: Semaglutide Dose 2
Participants will receive semaglutide orally.
Intervention: Drug: Semaglutide

Outcome(s)

• Primary Outcome: Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 52 ]

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 <=10.5% (91 mmol/mol), as determined by the central laboratory at screening.
Have been on stable diabetes treatment with metformin >=1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization.
Are of stable body 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

Exclude criteria

Have Type 1 Diabetes
Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors.
Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
Have a New York Heart Association functional classification IV congestive heart failure.
Have an estimated glomerular filtration rate (eGFR) <45 milliliter/minute (mL/min)/1.73 square meter (m2) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening.
Have a serum calcitonin level of >=35 nanogram/Liter (ng/L), as determined by the central laboratory at screening.
Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.

Related Information

• Primary Sponsor: Masaki Takeshi
• Secondary ID(s): NCT06045221