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

Purpose

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

Condition

T2DM (Type 2 Diabetes Mellitus)

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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 Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

Arm	Description	Assigned Intervention
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

Recruiting Locations

Ascletis Clinical Site
Riverside 5387877, California 5332921 92506

Ascletis Clinical Site
San Jose 5392171, California 5332921 95128

Ascletis Clinical Site
Denver 5419384, Colorado 5417618 80246

Ascletis Clinical Site
Miami 4164138, Florida 4155751 33143

Ascletis Clinical Site
Miami 4164138, Florida 4155751 33172

Ascletis Clinical Site
Decatur 4191124, Georgia 4197000 30030

Ascletis Clinical Site
Springfield 4409896, Missouri 4398678 65802

Ascletis Clinical Site
San Antonio 4726206, Texas 4736286 78240

More Details

NCT ID: NCT07321678
Status: Recruiting
Sponsor: Ascletis Pharma (China) Co., Limited

Study Contact

Ascletis Recruiting
+86 18042462262
clinicaltrials@ascletis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.