A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

Official title

A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily Oral ASC30 in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (AURORA-1)

Overview

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

• Drug ASC30 tablets A1
  ASC30 tablets A1 administered orally once daily.
• Drug Placebo
  Matching placebo tablets administered orally once daily.

Primary outcome measures

• Percent change in body weight from baseline to Week 72 [Time frame: Baseline to Week 72]

Secondary outcome measures (10)

• Change in waist circumference from baseline [Time frame: Baseline to Week 72]
• Change in systolic blood pressure (SBP) from baseline [Time frame: Baseline to Week 72]
• Percent change in fasting triglycerides from baseline [Time frame: Baseline to Week 72]
• Change in body mass index (BMI) from baseline (kg/m²) [Time frame: Baseline to Week 72]
• Change in HbA1c from baseline (%) [Time frame: Baseline to Week 72]
• Percent change from baseline in fasting non-HDL cholesterol [Time frame: Baseline to Week 72]
• Change in fasting glucose from baseline (mg/dL) [Time frame: Baseline to Week 72]
• Change in fasting insulin from baseline (pmol/L) [Time frame: Baseline to Week 72]
• Change in diastolic blood pressure (DBP) from baseline [Time frame: Baseline to Week 72]
• Percent change in fasting total cholesterol from baseline [Time frame: Baseline to Week 72]

Eligibility criteria

Inclusion criteria

• 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.
• 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).
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

• 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.
• Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening.
• Have an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2, as determined by the laboratory at screening.
• Have a history of acute or chronic pancreatitis any time prior to screening.
• Have known allergies or intolerance to other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs.
• Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Triple blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07743463 · ASC30-301

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗