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RecruitingPhase 3

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

Ascletis Pharma (China) Co., Limited · NCT07743450

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
1560
US sites recruiting
6
Study start
August 28, 2026
Record last updated
September 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: ASC30 tablets A1; Placebo

Conditions: Obesity; Overweight; Chronic Weight Management; Type 2 Diabetes Mellitus

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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 ≥ 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 at the investigator's discretion.

Recruiting US locations

  • AURORA-2 Clinical Site

    Phoenix, AZ 85020

    Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com

  • AURORA-2 Clinical Site

    Melbourne, FL 32934-8172

    Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com

  • AURORA-2 Clinical Site

    The Villages, FL 32162

    Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com

  • AURORA-2 Clinical Site

    Evansville, IN 47714-7513

    Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com

  • AURORA-2 Clinical Site

    Austin, TX 78744-1645

    Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com

  • AURORA-2 Clinical Site

    San Antonio, TX 78229-3272

    Site contact: Ascletis Recruiting · clinicaltrials@ascletis.com

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A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and… (NCT07743450) | Bored Studies