A Study to Evaluate the Efficacy, Safety, and Tolerability in Participants With Obesity or Overweight With Weight-Related Comorbidities

NCT ID: NCT07002905

Last Updated: 2025-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-03
• Study Completion Date: 2025-12-08

Brief Summary

This randomized, double-blind, placebo-controlled phase IIa study is designed to evaluate the efficacy, safety, and tolerability of ASC30 Tablets and ASC30 Tablets A1.

Conditions

Chronic Weight Management

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Cohort 1

Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.

Group Type: EXPERIMENTAL

ASC30 tablets or ASC30 tablets A1 or placebo

Intervention Type: DRUG

Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily

Cohort 2

Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.

Group Type: EXPERIMENTAL

ASC30 tablets or ASC30 tablets A1 or placebo

Intervention Type: DRUG

Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily

Cohort 3

Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.

Group Type: EXPERIMENTAL

ASC30 tablets or ASC30 tablets A1 or placebo

Intervention Type: DRUG

Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily

Cohort 4

Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.

Group Type: EXPERIMENTAL

ASC30 tablets or ASC30 tablets A1 or placebo

Intervention Type: DRUG

Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily

Cohort 5

Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.

Group Type: EXPERIMENTAL

ASC30 tablets or ASC30 tablets A1 or placebo

Intervention Type: DRUG

Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily

Cohort 6

Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.

Group Type: EXPERIMENTAL

ASC30 tablets or ASC30 tablets A1 or placebo

Intervention Type: DRUG

Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily

Cohort 7

Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.

Group Type: EXPERIMENTAL

ASC30 tablets or ASC30 tablets A1 or placebo

Intervention Type: DRUG

Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily

Interventions

ASC30 tablets or ASC30 tablets A1 or placebo

Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Have provided informed consent before initiation of any study-specific procedures.
• Male or female participants, non-smokers, between 18 and 75 years of age (both inclusive).
• No clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and other screening procedures.

Exclusion Criteria

• Have evidence of any clinically significant active or chronic disease.
• Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or rare forms of diabetes mellitus.
• Have an autoimmune disease, is immunosuppressed or is in any way immunocompromised.
• Have a history of acute or chronic pancreatitis.
• Participants with a known clinically significant gastric emptying abnormality.
• Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy.
• Have a history of any other condition (such as known drug or alcohol abuse, diagnosed eating disorder, or other psychiatric disorder) that, in the opinion of the Investigator, may preclude the participant from following and completing the protocol.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascletis Pharma (China) Co., Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ascletis Clinical Site

Rogers, Arkansas, United States

Ascletis Clinical Site

Fort Myers, Florida, United States

Ascletis Clinical Site

Miami, Florida, United States

Ascletis Clinical Site

Columbus, Ohio, United States

Ascletis Clinical Site

Bellaire, Texas, United States

Ascletis Clinical Site

San Antonio, Texas, United States

Countries

United States

Other Identifiers

ASC30-202

Identifier Type: -

Identifier Source: org_study_id