Chronic Weight Management, Obesity, Overweight, Type 2 Diabetes Mellitus
Conditions
Keywords
Obesity, Overweight, Type 2 Diabetes
Brief summary
Study ASC30-302 (AURORA-2) 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 and 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 ≥ 27 kg/m2 at screening. 3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. 4. Have a diagnosis of T2D according to the WHO classification or other locally applicable standards, with HbA1c \> 6.5% (48 mmol/mol) to ≤10.5% (91 mmol/mol) at screening.
Exclusion criteria
1. Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM. 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 glucagon-like peptide-1 Receptor Agonists (GLP-1 RA). 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 from baseline in body weight | Baseline to Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c (%) | Baseline to Week 72 |
| Change from baseline in fasting serum glucose (mg/dL) | Baseline to Week 72 |
| Change from baseline in systolic blood pressure (SBP) (mmHg) | Baseline to Week 72 |
| Percent change from baseline in fasting non-HDL cholesterol | Baseline to Week 72 |
| Percent change from baseline in fasting triglycerides | Baseline to Week 72 |
| Change from baseline in BMI (kg/m²) | Baseline to Week 72 |
| Change from baseline in fasting insulin (pmol/L) | Baseline to Week 72 |
| Change from baseline in waist circumference (cm) | Baseline to Week 72 |
| Change from baseline in diastolic blood pressure (DBP) (mmHg) | Baseline to Week 72 |
| Percent change from baseline in fasting total cholesterol | Baseline to Week 72 |
Countries
Czechia, Germany, Greece, Poland, United Kingdom, United States
Outcome results
None listed