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Completed
NCT07321678
A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus
Conditions: T2DM (Type 2 Diabetes Mellitus)
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 100
Sponsor: Ascletis Pharma (China) Co., Limited
Location: Ascletis Clinical Site Riverside California
Summary
This randomized, double-blind, placebo-controlled Phase II study is designed to evaluate the efficacy, safety, and tolerability of ASC30 oral tablets formulation in participants with Type 2 Diabetes Mellitus
Eligibility Criteria
Inclusion Criteria:
* Have Type 2 Diabetes (T2D)
* Have HbA1c ≥7.0% to ≤10.5% as determined by the central laboratory at screening.
* Stable body weight (less than 5% self-reported change within the previous 3 months).
* Have a BMI ≥23.0 kilogram/square meter (kg/m²) at screening.
Exclusion Criteria:
* Have any prior diagnosis of type 1 diabetes mellitus (T1DM), or rare forms of diabetes mellitus
* Have had more than 1 episode of severe hypoglycemia
* Have poorly controlled hypertension
* Have acute or chronic hepatitis and pancreatitis
* Have evidence of a significant active and uncontrolled medical condition
Source: ClinicalTrials.gov (NCT07321678). StuddyBuddy aggregates publicly available trial information.