Recruiting
Phase 3

ASC30

Sponsor:

Ascletis Pharma (China) Co., Limited

Code:

NCT07743450

Conditions

Obesity

Overweight

Chronic Weight Management

Type 2 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ASC30 tablets A1

Placebo

Study Details

Brief summary:

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.

Conditions

Obesity

Overweight

Chronic Weight Management

Type 2 Diabetes Mellitus

Study ID

NCT07743450

Start date

Aug, 2026

Status verified date

Jul, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1560 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ASC30 Cohort 1

Participants will receive oral ASC30 tablets A1.

experimental: ASC30 Cohort 2

Participants will receive oral ASC30 tablets A1.

experimental: ASC30 Cohort 3

Participants will receive oral ASC30 tabletsA1.

placebo comparator: Placebo Cohort 4

Participants will receive matching placebo tablets orally once daily.

Interventions

ASC30 tablets A1

ASC30 tablets A1 administered orally once daily.

Placebo

Matching placebo tablets administered orally once daily.

Primary outcome measure

  • Percent change from baseline in body weight [ Time Frame: Baseline to Week 72 ]

Central Contacts and Locations

Locations

AURORA-2 Clinical Site

Recruiting

Phoenix, Arizona, United States, 85020

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-2 Clinical Site

Recruiting

Melbourne, Florida, United States, 32934-8172

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-2 Clinical Site

Recruiting

The Villages, Florida, United States, 32162

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-2 Clinical Site

Recruiting

Evansville, Indiana, United States, 47714-7513

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-2 Clinical Site

Recruiting

Austin, Texas, United States, 78744-1645

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

AURORA-2 Clinical Site

Recruiting

San Antonio, Texas, United States, 78229-3272

Contacts

Ascletis Recruiting

clinicaltrials@ascletis.com

More Information

Sponsor

Ascletis Pharma (China) Co., Limited

Last update posted

Aug 14, 2026

Last verified

Jul, 2026

Keywords

  • Obesity
  • Overweight
  • Type 2 Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ascletis Pharma (China) Co., Limited on 2026-08-14.