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

NCT07321678 · tracked via the Priya Life Science USA tracker

Sponsor

Ascletis Pharma (China) Co., Limited

Phase

Phase 2

Started

2026-01-22

Last updated

2026-09-21

Condition(s) studied

T2DM (Type 2 Diabetes Mellitus)

Investigational drug(s) / intervention(s)

ASC30 tabletsPlacebo

ASC30 tablets: ASC30 tablets administered orally once daily

Placebo: Placebo administered orally once daily

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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

Primary outcome measure(s)

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

Trial sites (8)

Facility	City	Region
Ascletis Clinical Site	Riverside	California
Ascletis Clinical Site	San Jose	California
Ascletis Clinical Site	Denver	Colorado
Ascletis Clinical Site	Miami	Florida
Ascletis Clinical Site	Miami	Florida
Ascletis Clinical Site	Decatur	Georgia
Ascletis Clinical Site	Springfield	Missouri
Ascletis Clinical Site	San Antonio	Texas

More Ascletis Pharma (China) Co., Limited trials in the USA

A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes Recruiting

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Efficacy of ASC50 Tables in Healthy Participants and Participants With Plaque Psoriasis Recruiting

A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07321678 on ClinicalTrials.gov ↗ ← All trials in the USA