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

NCT ID: NCT07321678

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2026-08-31

Brief Summary

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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

Detailed Description

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Conditions

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T2DM (Type 2 Diabetes Mellitus)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ASC30 tablets Dose 1

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

Group Type EXPERIMENTAL

ASC30 tablets

Intervention Type DRUG

ASC30 tablets administered orally once daily

ASC30 tablets Dose 2

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

Group Type EXPERIMENTAL

ASC30 tablets

Intervention Type DRUG

ASC30 tablets administered orally once daily

ASC30 tablets Dose 3

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

Group Type EXPERIMENTAL

ASC30 tablets

Intervention Type DRUG

ASC30 tablets administered orally once daily

Placebo

Participants will receive Placebo administered orally once daily.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo administered orally once daily

Interventions

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ASC30 tablets

ASC30 tablets administered orally once daily

Intervention Type DRUG

Placebo

Placebo administered orally once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ascletis Pharma (China) Co., Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ascletis Clinical Site

Riverside, California, United States

Site Status RECRUITING

Ascletis Clinical Site

San Jose, California, United States

Site Status RECRUITING

Ascletis Clinical Site

Denver, Colorado, United States

Site Status RECRUITING

Ascletis Clinical Site

Miami, Florida, United States

Site Status RECRUITING

Ascletis Clinical Site

Miami, Florida, United States

Site Status RECRUITING

Ascletis Clinical Site

Decatur, Georgia, United States

Site Status RECRUITING

Ascletis Clinical Site

Springfield, Missouri, United States

Site Status RECRUITING

Ascletis Clinical Site

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Ascletis Recruiting

Role: CONTACT

+86 18042462262

Other Identifiers

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ASC30-203

Identifier Type: -

Identifier Source: org_study_id

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