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NCT Number: NCT07743450

A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes

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.

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Key information

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 ≥ 27 kg/m2 at screening.
  • Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
  • 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

  • Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
  • 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 glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
  • 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 from baseline in body weight

    Time frame: Baseline to Week 72

Secondary outcomes

  1. Change from baseline in HbA1c (%)

    Time frame: Baseline to Week 72

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

    Time frame: Baseline to Week 72

  3. Change from baseline in systolic blood pressure (SBP) (mmHg)

    Time frame: Baseline to Week 72

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

    Time frame: Baseline to Week 72

  5. Percent change from baseline in fasting triglycerides

    Time frame: Baseline to Week 72

  6. Change from baseline in BMI (kg/m²)

    Time frame: Baseline to Week 72

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

    Time frame: Baseline to Week 72

  8. Change from baseline in waist circumference (cm)

    Time frame: Baseline to Week 72

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

    Time frame: Baseline to Week 72

  10. Percent change from baseline in fasting total cholesterol

    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 Type 2 Diabetes Mellitus (AURORA-2)

Acronym: AURORA-2

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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