Chronic Weight Management, Obesity, Overweight
Conditions
Keywords
Obesity, Overweight, Weight Management
Brief summary
Study ASC30-301 (AURORA-1) is a Phase III, global, multicenter, randomized, double-blind, placebo-controlled study to investigate the long-term efficacy, safety, and tolerability of three maintenance doses of once-daily oral ASC30 compared with placebo in participants with obesity or overweight without T2DM.
Interventions
DRUGASC30 tablets A1
ASC30 tablets A1 administered orally once daily.
DRUGPlacebo
Matching placebo tablets administered orally once daily.
Sponsors
Ascletis Pharma (China) Co., Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Participant must be ≥18 years of age inclusive, or the legal age of consent in the jurisdiction in which the study is taking place at screening. 2. Have a BMI ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening: * Hypertension * Dyslipidemia * Obstructive sleep apnea * Cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure). 3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
Exclusion criteria
1. Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma. Participants with a history of gestational diabetes are eligible to participate in this trial. 2. Have a self-reported change in body weight \>5 kg (11 pounds) within 3 months prior to screening. 3. Have an estimated glomerular filtration rate (eGFR) \< 15 mL/min/1.73 m2, as determined by the laboratory at screening. 4. Have a history of acute or chronic pancreatitis any time prior to screening. 5. Have known allergies or intolerance to other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs. 6. Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2. 7. Are currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study at the investigator's discretion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight from baseline to Week 72 | Baseline to Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| Change in waist circumference from baseline | Baseline to Week 72 |
| Change in systolic blood pressure (SBP) from baseline | Baseline to Week 72 |
| Percent change in fasting triglycerides from baseline | Baseline to Week 72 |
| Change in body mass index (BMI) from baseline (kg/m²) | Baseline to Week 72 |
| Change in HbA1c from baseline (%) | Baseline to Week 72 |
| Percent change from baseline in fasting non-HDL cholesterol | Baseline to Week 72 |
| Change in fasting glucose from baseline (mg/dL) | Baseline to Week 72 |
| Change in fasting insulin from baseline (pmol/L) | Baseline to Week 72 |
| Change in diastolic blood pressure (DBP) from baseline | Baseline to Week 72 |
| Percent change in fasting total cholesterol from baseline | Baseline to Week 72 |
Countries
Canada, Czechia, Germany, Greece, Poland, United Kingdom, United States
Outcome results
None listed