Status:
COMPLETED
A Study to Evaluate the Efficacy, Safety, and Tolerability in Participants With Obesity or Overweight With Weight-Related Comorbidities
Lead Sponsor:
Ascletis Pharma (China) Co., Limited
Conditions:
Chronic Weight Management
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2025
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT07002905
Start Date
July 3 2025
End Date
December 8 2025
Last Update
December 15 2025
Active Locations (6)
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1
Ascletis Clinical Site
Rogers, Arkansas, United States, 72758
2
Ascletis Clinical Site
Fort Myers, Florida, United States, 33912
3
Ascletis Clinical Site
Miami, Florida, United States, 33172
4
Ascletis Clinical Site
Columbus, Ohio, United States, 43212