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

Ascletis Pharma (China) Co., Limited

Status and phase: Completed; Phase 2

Conditions: Chronic Weight Management

Treatments: Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07002905

ASC30-202

Details and patient eligibility

About

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.

Enrollment: 125 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

125 participants in 7 patient groups

Cohort 1

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 3

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 4

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 5

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 6

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 7

Experimental group

Description:

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

Treatment:

Drug: ASC30 tablets or ASC30 tablets A1 or placebo