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Not yet recruiting 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

Phase III Interventional Obesity or Overweight With Type 2 Diabetes Mellitus Chronic Weight Management

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ASC30 tablets A1, Placebo.
Who it may be relevant to
Registry conditions: Obesity or Overweight With Type 2 Diabetes Mellitus, Chronic Weight Management. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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 Type 2 Diabetes Mellitus (AURORA-2)

Overview

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

  • 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 from baseline in body weight [Time frame: Baseline to Week 72]
Secondary outcome measures (10)
  • Change from baseline in HbA1c (%) [Time frame: Baseline to Week 72]
  • Change from baseline in fasting serum glucose (mg/dL) [Time frame: Baseline to Week 72]
  • Change from baseline in systolic blood pressure (SBP) (mmHg) [Time frame: Baseline to Week 72]
  • Percent change from baseline in fasting non-HDL cholesterol [Time frame: Baseline to Week 72]
  • Percent change from baseline in fasting triglycerides [Time frame: Baseline to Week 72]
  • Change from baseline in BMI (kg/m²) [Time frame: Baseline to Week 72]
  • Change from baseline in fasting insulin (pmol/L) [Time frame: Baseline to Week 72]
  • Change from baseline in waist circumference (cm) [Time frame: Baseline to Week 72]
  • Change from baseline in diastolic blood pressure (DBP) (mmHg) [Time frame: Baseline to Week 72]
  • Percent change from baseline in fasting total cholesterol [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 ≥ 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.

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: NCT07743450 · ASC30-302

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗