ASC30 Tablets for Type 2 Diabetes

Recruiting at 6 trial locations

Overseen By Ascletis Recruiting

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ascletis Pharma (China) Co., Limited

Disqualifiers: Type 1 diabetes, Severe hypoglycemia, Hypertension, Hepatitis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Are You a Good Fit for This Trial?

This trial is for individuals with Type 2 Diabetes Mellitus. Participants should meet certain health criteria, but specific inclusion and exclusion details are not provided.

Inclusion Criteria

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)

I have Type 2 Diabetes.

Exclusion Criteria

I have experienced severe low blood sugar more than once.

My high blood pressure is not well-managed.

I have been diagnosed with type 1 diabetes or a rare form of diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ASC30 tablets or placebo once daily

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ASC30 Tablets

Trial Overview

The study tests the effectiveness of ASC30 tablets compared to a placebo in managing Type 2 Diabetes. It's a Phase II trial where participants are randomly assigned to either the treatment or placebo group without knowing which one they receive.

How Is the Trial Designed?

Group I: ASC30 tablets Dose 3 Experimental Treatment 1 Intervention

Participants will receive ASC30 tablets Dose 3 administered orally once daily.

Group II: ASC30 tablets Dose 2 Experimental Treatment 1 Intervention

Participants will receive ASC30 tablets Dose 2 administered orally once daily.

Group III: ASC30 tablets Dose 1 Experimental Treatment 1 Intervention

Participants will receive ASC30 tablets Dose 1 administered orally once daily.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive Placebo administered orally once daily.

Who Is Running the Clinical Trial?

Ascletis Pharma (China) Co., Limited

Lead Sponsor

Trials

3

Recruited

180+