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OpenTrials
Completed

NCT Number: NCT07002905

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

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.

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Key information

Conditions

Chronic Weight Management

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ascletis Clinical Site, Rogers, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASC30 tablets or ASC30 tablets A1 or placebo

Drug

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

Primary outcomes

  1. Percent change in body weight from Baseline up to Week 13

    Time frame: Baseline and Week 13

Secondary outcomes

  1. Change in body weight (absolute) from Baseline up to Week 13

    Time frame: Baseline and Week 13

  2. Change in waist circumference from Baseline up to Week 13

    Time frame: Baseline and Week 13

  3. Change in body mass index from Baseline to Week 13

    Time frame: Baseline and Week 13

  4. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)

    Time frame: Baseline and Week 13

Sponsors and collaborators

Lead sponsor

Ascletis Pharma (China) Co., Limited

Industry

Registry information

Official study title

A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity or Overweight With Weight-Related Comorbidities

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 4, 2025
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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