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

Conditions

• Chronic Weight Management
• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• ASC30 tablets A1 — DRUG
  ASC30 tablets A1 administered orally once daily.
• Placebo — DRUG
  Matching placebo tablets administered orally once daily.

Study Details

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.

Key Dates

First listed

Aug 3, 2026

Start date

Aug 31, 2026

Status verified

Jul 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

3,003 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

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 tablets A1.
• Placebo Comparator: Placebo Cohort 4
  Participants will receive matching placebo tablets orally once daily.

Primary Outcome Measure

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

Locations (67)

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