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

Ascletis Pharma (China) Co., Limited

Status and phase: Enrolling; Phase 2

Conditions: T2DM (Type 2 Diabetes Mellitus)

Treatments: Drug: ASC30 tablets; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07321678

ASC30-203

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups, including a placebo group

ASC30 tablets Dose 1

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets

ASC30 tablets Dose 2

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets

ASC30 tablets Dose 3

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo administered orally once daily.

Treatment:

Drug: Placebo