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

Ascletis Pharma (China) Co., Limited

Status and phase: Enrolling; Phase 3

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

Treatments: Drug: ASC30 tablets A1; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07743450

ASC30-302

Details and patient eligibility

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.

Enrollment: 1,560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Have a BMI ≥ 27 kg/m2 at screening.
3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.
4. 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

1. Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.
2. Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening.
3. Have an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2, as determined by the laboratory at screening.
4. Have a history of acute or chronic pancreatitis any time prior to screening.
5. Have known allergies or intolerance to glucagon-like peptide-1 Receptor Agonists (GLP-1 RA).
6. Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2.
7. 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,560 participants in 4 patient groups, including a placebo group

ASC30 Cohort 1

Experimental group

Description:

Participants will receive oral ASC30 tablets A1.

Treatment:

Drug: ASC30 tablets A1

ASC30 Cohort 2

Experimental group

Description:

Participants will receive oral ASC30 tablets A1.

Treatment:

Drug: ASC30 tablets A1

ASC30 Cohort 3

Experimental group

Description:

Participants will receive oral ASC30 tabletsA1.

Treatment:

Drug: ASC30 tablets A1

Placebo Cohort 4

Placebo Comparator group

Description:

Participants will receive matching placebo tablets orally once daily.

Treatment:

Drug: Placebo