Clinical trial NCT07002905: A Study to Evaluate the Efficacy, Safety, and Tolerability in Participants With Obesity or Overweight With Weight-Related Comorbidities
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Weight Management
Lead sponsor: Ascletis Pharma Inc
Sponsor class: INDUSTRY
First posted: 2025-06-04
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent change in body weight from Baseline up to Week 13
timeFrame: Baseline and Week 13
Secondary outcomes:
measure: Change in body weight (absolute) from Baseline up to Week 13
timeFrame: Baseline and Week 13
measure: Change in waist circumference from Baseline up to Week 13
timeFrame: Baseline and Week 13
measure: Change in body mass index from Baseline to Week 13
timeFrame: Baseline and Week 13
measure: Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
timeFrame: Baseline and Week 13
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Ascletis Clinical Site
state: Arkansas
city: Fort Myers
country: United States
facility: Ascletis Clinical Site
state: Florida
city: Miami
country: United States
facility: Ascletis Clinical Site
state: Florida
city: Columbus
country: United States
facility: Ascletis Clinical Site
state: Ohio
city: Bellaire
country: United States
facility: Ascletis Clinical Site
state: Texas
city: San Antonio
country: United States
facility: Ascletis Clinical Site
state: Texas
Study officials:
References: