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NCT Number: NCT07321678

A 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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

T2DM (Type 2 Diabetes Mellitus) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ascletis Clinical Site, Riverside, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ASC30 tablets

Drug

ASC30 tablets administered orally once daily

Placebo

Drug

Placebo administered orally once daily

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Ascletis Pharma (China) Co., Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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