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

NOT_RECRUITINGPhase 2Sponsored by Ascletis Pharma (China) Co., Limited
No longer actively recruiting
PhasePhase 2
SponsorAscletis Pharma (China) Co., Limited
Started2026-01
Est. completion2026-08
Eligibility
Age18 Years – 75 Years
Healthy vol.Accepted
Locations8 sites
View on ClinicalTrials.gov →

NCT07321678

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 Years – 75 YearsHealthy volunteers accepted
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

Conditions2

DiabetesT2DM (Type 2 Diabetes Mellitus)

Interventions1

ASC30 tablets

Locations8 sites

Ascletis Clinical Site
Riverside, California, 92506
Ascletis Clinical Site
San Jose, California, 95128
Ascletis Clinical Site
Denver, Colorado, 80246
Ascletis Clinical Site
Miami, Florida, 33143
Ascletis Clinical Site
Miami, Florida, 33172

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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