RecruitingPhase 2NCT07321678
A Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets in Participants With Type 2 Diabetes Mellitus
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
Sponsor
Ascletis Pharma (China) Co., Limited
Enrollment
100 participants
Start Date
Jan 1, 2026
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- 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 Criteria5
- 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
Interventions
DRUGASC30 tablets
ASC30 tablets administered orally once daily
DRUGPlacebo
Placebo administered orally once daily
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07321678
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