A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus

NCT07321678 · Ascletis Pharma Inc

Recruiting

In plain English

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Official title

A Phase II, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus

About this study

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

Study design

Enrollment target: 100 participants

Allocation: randomized

Masking: quadruple

Age groups: adult, older_adult

Timeline

Starts: 2026-01

Estimated completion: 2026-08

Last updated: 2026-01-07

Interventions

Drug: ASC30 tabletsDrug: Placebo

Primary outcomes

• Mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group (Baseline and end of Week 13)

Sponsor

Ascletis Pharma (China) Co., Limited · industry