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Clinical Trials in the UK / NCT07743463
Recruiting Phase 3

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 · tracked via the Priya Life Science UK tracker
Sponsor
Ascletis Pharma (China) Co., Limited
Phase
Phase 3
Started
2026-08-31
Last updated
2026-09-16

Condition(s) studied

ObesityOverweightChronic Weight Management

Investigational drug(s) / intervention(s)

ASC30 tablets A1Placebo

ASC30 tablets A1: ASC30 tablets A1 administered orally once daily.

Placebo: Matching placebo tablets administered orally once daily.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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 ≥ 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). 3. Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight. Exclusion Criteria: 1. 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. 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 other glucagon-like peptide-1 Receptor Agonists (GLP-1 RA) analogs. 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 at the investigator's discretion.

Primary outcome measure(s)

Trial sites (122)

FacilityCityRegionStatus
AURORA-1 Clinical Site Birmingham Alabama Not Yet Recruiting
AURORA-1 Clinical Site Huntsville Alabama Not Yet Recruiting
AURORA-1 Clinical Site Phoenix Arizona Recruiting
AURORA-1 Clinical Site Tucson Arizona Not Yet Recruiting
AURORA-1 Clinical Site Little Rock Arkansas Not Yet Recruiting
AURORA-1 Clinical Site Banning California Not Yet Recruiting
AURORA-1 Clinical Site Chula Vista California Not Yet Recruiting
AURORA-1 Clinical Site Covina California Not Yet Recruiting
AURORA-1 Clinical Site Gardena California Not Yet Recruiting
AURORA-1 Clinical Site La Mesa California Not Yet Recruiting
AURORA-1 Clinical Site Los Angeles California Not Yet Recruiting
AURORA-1 Clinical Site Tarzana California Not Yet Recruiting
AURORA-1 Clinical Site Tustin California Not Yet Recruiting
AURORA-1 Clinical Site Washington D.C. District of Columbia Not Yet Recruiting
AURORA-1 Clinical Site Boca Raton Florida Not Yet Recruiting
AURORA-1 Clinical Site Daytona Beach Florida Not Yet Recruiting
AURORA-1 Clinical Site Jacksonville Florida Not Yet Recruiting
AURORA-1 Clinical Site Leesburg Florida Not Yet Recruiting
AURORA-1 Clinical Site Melbourne Florida Recruiting
AURORA-1 Clinical Site South Miami Florida Not Yet Recruiting
AURORA-1 Clinical Site Tampa Florida Not Yet Recruiting
AURORA-1 Clinical Site The Villages Florida Recruiting
AURORA-1 Clinical Site Winter Park Florida Not Yet Recruiting
AURORA-1 Clinical Site Canton Georgia Not Yet Recruiting
AURORA-1 Clinical Site Decatur Georgia Not Yet Recruiting
AURORA-1 Clinical Site Union City Georgia Not Yet Recruiting
AURORA-1 Clinical Site Boise Idaho Not Yet Recruiting
AURORA-1 Clinical Site Schaumburg Illinois Not Yet Recruiting
AURORA-1 Clinical Site Evansville Indiana Recruiting
AURORA-1 Clinical Site Indianapolis Indiana Not Yet Recruiting
AURORA-1 Clinical Site Valparaiso Indiana Not Yet Recruiting
AURORA-1 Clinical Site Kansas City Kansas Not Yet Recruiting
AURORA-1 Clinical Site Baton Rouge Louisiana Not Yet Recruiting
AURORA-1 Clinical Site Bowie Maryland Not Yet Recruiting
AURORA-1 Clinical Site Rockville Maryland Not Yet Recruiting
AURORA-1 Clinical Site Gulfport Mississippi Not Yet Recruiting
AURORA-1 Clinical Site Jackson Mississippi Not Yet Recruiting
AURORA-1 Clinical Site Olive Branch Mississippi Not Yet Recruiting
AURORA-1 Clinical Site St Louis Missouri Not Yet Recruiting
AURORA-1 Clinical Site Las Vegas Nevada Not Yet Recruiting

+ 82 more sites — see the full list on the official registry below.

More Ascletis Pharma (China) Co., Limited trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07743463 on ClinicalTrials.gov ↗ ← All trials in the UK