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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2041230086

Registered date:04/10/2023

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedType 2 Diabetes
Date of first enrollment24/11/2023
Target sample size1576
Countries of recruitmentArgentina,Japan,China,Japan,Mexico,Japan,Puerto Rico,Japan,United States,Japan
Study typeInterventional
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 OutcomeChange from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 52 ]
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximumNot applicable
GenderBoth
Include criteriaHave 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 criteriaHave 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

Contact

Public contact
Name Trial Guide Call Center
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
E-mail LTG_CallCenter@lists.lilly.com
Affiliation Eli Lilly Japan K.K.
Scientific contact
Name Takeshi Masaki
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
E-mail LTG_CallCenter@lists.lilly.com
Affiliation Eli Lilly Japan K.K.