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

RECRUITINGPHASE2

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

NCT07321678•Ascletis Pharma (China) Co., Limited

View on ClinicalTrials.gov

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

Age

18 - 75 years

Sex

ALL

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

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

Key Dates

Start Date

January 1, 2026

Primary Completion Date

August 1, 2026

Completion Date

August 1, 2026

Last Updated

January 7, 2026

Enrollment

100

ESTIMATED participants

Conditions

T2DM (Type 2 Diabetes Mellitus)

Interventions

ASC30 tablets

DRUG

Placebo

DRUG

Contacts

Ascletis Recruiting

CONTACT

+86 18042462262 clinicaltrials@ascletis.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 7, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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