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OpenTrials
Completed

NCT Number: NCT06680440

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of ASC30 Tablets and ASC30 Tablets A1 in Participants With Obesity

This is a phase I, randomized, double-blind, placebo-controlled, single and multiple ascending dose study to evaluate the safety, tolerability, pharmacokinetics, efficacy, food effect of ASC30 Tablets or ASC30 Tablets A1 in participants with obesity.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Ascletis clinical site

Salt Lake City, Utah, 84124, United States

Who can participate

Healthy volunteers accepted: Yes

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 65 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

Drug

Tablet, QD

Placebo

Other

Tablets, QD

Primary outcomes

  1. Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (SAD)

    Time frame: Up to Day 8

    A summary of AEs, SAEs and other non-serious adverse events

  2. Incidence of AEs, SAEs (Safety and Tolerability) of ASC30 (MAD)

    Time frame: Up to Day 28

    A summary of AEs, SAEs and other non-serious adverse events

Secondary outcomes

  1. Cmax of ASC30 (SAD)

    Time frame: Up to Day 8

    PK parameters of ASC30

  2. Cmax of ASC30 (MAD)

    Time frame: Up to Day 28

    PK parameters of ASC30

  3. Change From Baseline in Body Weight (MAD)

    Time frame: Up to Day 28

    Change From Baseline in Body Weight

Sponsors and collaborators

Lead sponsor

Ascletis Pharma (China) Co., Limited

Industry

Registry information

Official study title

A Phase I Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ASC30 Tablets in Participants With Obesity

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
May 20, 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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