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

Phase 2

Recruiting

• Conditions: Chronic Weight Management
• Interventions: Drug: ASC30 tablets or ASC30 tablets A1 or placebo

• Registration Number: NCT07002905
• Lead Sponsor: Ascletis Pharma (China) Co., Limited

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-25
• Last Update Submitted: 2025-05-25
• Study Start: 2025-06
• Study First Posted: 2025-06-04
• Last Update Posted: 2025-06-04
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	ASC30 tablets or ASC30 tablets A1 or placebo	Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Cohort 2	ASC30 tablets or ASC30 tablets A1 or placebo	Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Cohort 3	ASC30 tablets or ASC30 tablets A1 or placebo	Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Cohort 4	ASC30 tablets or ASC30 tablets A1 or placebo	Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Cohort 5	ASC30 tablets or ASC30 tablets A1 or placebo	Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Cohort 6	ASC30 tablets or ASC30 tablets A1 or placebo	Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.
Cohort 7	ASC30 tablets or ASC30 tablets A1 or placebo	Participants will receive ASC30 tablets/ASC30 tablets A1 or Placebo administered orally once daily.

Primary Outcome Measures

Name	Time	Method
Percent change in body weight from Baseline up to Week 13	Baseline and Week 13

Secondary Outcome Measures

Name	Time	Method
Change in body weight (absolute) from Baseline up to Week 13	Baseline and Week 13
Change in waist circumference from Baseline up to Week 13	Baseline and Week 13
Change in body mass index from Baseline to Week 13	Baseline and Week 13
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)	Baseline and Week 13

Trial Locations

Locations (1)

Ascletis Clinical Site; 🇺🇸 San Antonio, Texas, United States