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

Plain Language Summary

Simplified for easier understanding

This study is testing a new oral medication called ASC30 to see if it safely and effectively lowers blood sugar in people with type 2 diabetes. Participants will take the drug as a tablet over a study period. **You may be eligible if...** - You have been diagnosed with type 2 diabetes - Your HbA1c (a measure of blood sugar control over 3 months) is between 7.0% and 10.5% - Your weight has been stable (less than 5% change) in the last 3 months - Your BMI is 23 or above **You may NOT be eligible if...** - You have type 1 diabetes or a rare form of diabetes - You have had more than one episode of severe low blood sugar (hypoglycemia) - You have poorly controlled high blood pressure - You have active hepatitis or pancreatitis - You have a serious ongoing medical condition that is not well-controlled Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGASC30 tablets

ASC30 tablets administered orally once daily

DRUGPlacebo

Placebo administered orally once daily


Locations(8)

Ascletis Clinical Site

Riverside, California, United States

Ascletis Clinical Site

San Jose, California, United States

Ascletis Clinical Site

Denver, Colorado, United States

Ascletis Clinical Site

Miami, Florida, United States

Ascletis Clinical Site

Miami, Florida, United States

Ascletis Clinical Site

Decatur, Georgia, United States

Ascletis Clinical Site

Springfield, Missouri, United States

Ascletis Clinical Site

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT07321678


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