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

April 26, 2026 updated by: Ascletis Pharma (China) Co., Limited

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Riverside, California, United States, 92506
        • Ascletis Clinical Site
      • San Jose, California, United States, 95128
        • Ascletis Clinical Site
    • Colorado
      • Denver, Colorado, United States, 80246
        • Ascletis Clinical Site
    • Florida
      • Miami, Florida, United States, 33172
        • Ascletis Clinical Site
      • Miami, Florida, United States, 33143
        • Ascletis Clinical Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Ascletis Clinical Site
    • Missouri
      • Springfield, Missouri, United States, 65802
        • Ascletis Clinical Site
    • Texas
      • San Antonio, Texas, United States, 78240
        • Ascletis Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ASC30 tablets Dose 1
Participants will receive ASC30 tablets Dose 1 administered orally once daily.
Drug: ASC30 tablets
ASC30 tablets administered orally once daily
Experimental: ASC30 tablets Dose 2
Participants will receive ASC30 tablets Dose 2 administered orally once daily.
Drug: ASC30 tablets
ASC30 tablets administered orally once daily
Experimental: ASC30 tablets Dose 3
Participants will receive ASC30 tablets Dose 3 administered orally once daily.
Drug: ASC30 tablets
ASC30 tablets administered orally once daily
Placebo Comparator: Placebo
Participants will receive Placebo administered orally once daily.
Drug: Placebo
Placebo administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in HbA1c up to 13 weeks in the treatment group compared with the placebo group
Time Frame: Baseline and end of Week 13
Baseline and end of Week 13

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline in fasting blood glucose up to 13 weeks in the treatment group compared with the placebo group
Time Frame: Baseline and end of Week 13
Baseline and end of Week 13
Mean change from baseline in body weight up to 13 weeks in the treatment group compared with placebo group
Time Frame: Baseline and end of Week 13
Baseline and end of Week 13

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ascletis Pharma (China) Co., Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

August 1, 2026

Study Registration Dates

First Submitted

January 5, 2026

First Submitted That Met QC Criteria

January 5, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

April 30, 2026

Last Update Submitted That Met QC Criteria

April 26, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASC30-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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