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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Chronic Weight Management
Intervention / Treatment

-

Contacts and Locations

Rogers

Ascletis Clinical Site, Rogers, Arkansas, United States, 72758

Fort Myers

Ascletis Clinical Site, Fort Myers, Florida, United States, 33912

Miami

Ascletis Clinical Site, Miami, Florida, United States, 33172

Columbus

Ascletis Clinical Site, Columbus, Ohio, United States, 43212

Bellaire

Ascletis Clinical Site, Bellaire, Texas, United States, 77401

San Antonio

Ascletis Clinical Site, San Antonio, Texas, United States, 78240

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Ascletis Pharma (China) Co., Limited,

Study Record Dates

2026-01