Chronic Weight Management
Conditions
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.
Interventions
DRUGASC30 tablets or ASC30 tablets A1 or placebo
Drug: ASC30 tablets or ASC30 tablets A1 administered orally daily Drug: Placebo administered orally daily
Sponsors
Ascletis Pharma (China) Co., Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight from Baseline up to Week 13 | Baseline and Week 13 |
Secondary
| Measure | Time frame |
|---|---|
| Change in body weight (absolute) from Baseline up to Week 13 | Baseline and Week 13 |
| Change in waist circumference from Baseline up to Week 13 | Baseline and Week 13 |
| Change in body mass index from Baseline to Week 13 | Baseline and Week 13 |
| Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) | Baseline and Week 13 |
Countries
United States
Outcome results
None listed