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

NCT07002905 | Completed Phase 2 FDA Drug

• 1 other identifier: ASC30-202
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 6

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

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight from Baseline up to Week 13

  Baseline and Week 13

Secondary Outcomes (4)

• 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

Study Arms (7)

Cohort 1

EXPERIMENTAL

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

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 2

EXPERIMENTAL

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

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 3

EXPERIMENTAL

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

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 4

EXPERIMENTAL

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

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 5

EXPERIMENTAL

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

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 6

EXPERIMENTAL

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

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Cohort 7

EXPERIMENTAL

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

Drug: ASC30 tablets or ASC30 tablets A1 or placebo

Interventions

ASC30 tablets or ASC30 tablets A1 or placebo DRUG

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

Cohort 1; Cohort 2; Cohort 3; Cohort 4; Cohort 5; Cohort 6; Cohort 7

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ascletis Pharma (China) Co., Limited: lead

Study Sites (6)

Ascletis Clinical Site

Rogers, Arkansas, 72758, United States

Location

Ascletis Clinical Site

Fort Myers, Florida, 33912, United States

Location

Ascletis Clinical Site

Miami, Florida, 33172, United States

Location

Ascletis Clinical Site

Columbus, Ohio, 43212, United States

Location

Ascletis Clinical Site

Bellaire, Texas, 77401, United States

Location

Ascletis Clinical Site

San Antonio, Texas, 78240, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: June 4, 2025
• Study Start: July 3, 2025
• Primary Completion: December 8, 2025
• Study Completion: December 8, 2025
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)