A Study to Evaluate the Efficacy, Safety, and Tolerability in Participants With Obesity or Overwe… (NCT07002905) | Clinical Trial Compass
CompletedPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability in Participants With Obesity or Overweight With Weight-Related Comorbidities
United States125 participantsStarted 2025-07-03
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Percent change in body weight from Baseline up to Week 13