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NCT Number: NCT07743463

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

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.

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Key information

Conditions

Obesity or Overweight With Weight-Related Comorbidities Body Weight Chronic Weight Management Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASC30 tablets A1

Drug

ASC30 tablets A1 administered orally once daily.

Placebo

Drug

Matching placebo tablets administered orally once daily.

Primary outcomes

  1. Percent change in body weight from baseline to Week 72

    Time frame: Baseline to Week 72

Secondary outcomes

  1. Change in waist circumference from baseline

    Time frame: Baseline to Week 72

  2. Change in systolic blood pressure (SBP) from baseline

    Time frame: Baseline to Week 72

  3. Percent change in fasting triglycerides from baseline

    Time frame: Baseline to Week 72

  4. Change in body mass index (BMI) from baseline (kg/m²)

    Time frame: Baseline to Week 72

  5. Change in HbA1c from baseline (%)

    Time frame: Baseline to Week 72

  6. Percent change from baseline in fasting non-HDL cholesterol

    Time frame: Baseline to Week 72

  7. Change in fasting glucose from baseline (mg/dL)

    Time frame: Baseline to Week 72

  8. Change in fasting insulin from baseline (pmol/L)

    Time frame: Baseline to Week 72

  9. Change in diastolic blood pressure (DBP) from baseline

    Time frame: Baseline to Week 72

  10. Percent change in fasting total cholesterol from baseline

    Time frame: Baseline to Week 72

Sponsors and collaborators

Lead sponsor

Ascletis Pharma (China) Co., Limited

Industry

Registry information

Official study 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)

Acronym: AURORA-1

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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