A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities

NCT07743463 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: ASC30-301
• Study Type: interventional
• Target: 3,003
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study ASC30-301 (AURORA-1) 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 without T2DM.

Conditions

Chronic Weight Management; Obesity or Overweight With Weight-Related Comorbidities

Keywords

Obesity; Overweight; Weight Management

Outcome Measures

Primary Outcomes (1)

• Percent change in body weight from baseline to Week 72

  Baseline to Week 72

Secondary Outcomes (10)

• Change in waist circumference from baseline

  Baseline to Week 72

• Change in systolic blood pressure (SBP) from baseline

  Baseline to Week 72

• Percent change in fasting triglycerides from baseline

  Baseline to Week 72

• Change in body mass index (BMI) from baseline (kg/m²)

  Baseline to Week 72

• Change in HbA1c from baseline (%)

  Baseline to Week 72

Study Arms (4)

Cohort 1

EXPERIMENTAL

Participants will receive oral ASC30 tablets A1.

Drug: ASC30 tablets A1

Cohort 2

EXPERIMENTAL

Participants will receive oral ASC30 tablets A1.

Drug: ASC30 tablets A1

Cohort 3

EXPERIMENTAL

Participants will receive oral ASC30 tablets A1.

Drug: ASC30 tablets A1

Cohort 4

PLACEBO COMPARATOR

Participants will receive matching placebo tablets orally once daily.

Drug: Placebo

Interventions

ASC30 tablets A1 DRUG

ASC30 tablets A1 administered orally once daily.

Cohort 1; Cohort 2; Cohort 3

Placebo DRUG

Matching placebo tablets administered orally once daily.

Cohort 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≥ 30 kg/m2 or a BMI ≥ 27 kg/m2 and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:
• Hypertension
• Dyslipidemia
• Obstructive sleep apnea
• Cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

You may not qualify if:

• Have any prior diagnosis of diabetes mellitus (T1DM or T2DM), or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma. Participants with a history of gestational diabetes are eligible to participate in this trial.
• 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 other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs.
• 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.

Sponsors & Collaborators

• Ascletis Pharma (China) Co., Limited: lead

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: August 3, 2026

Record last verified: 2026-07