Daily ASC30 pill for adults with obesity or overweight and type 2 diabetes
Tests a daily ASC30 pill in adults with obesity and type 2 diabetes.
Plain-language title generated from the registry record
Registry title: A Study of Once-daily Oral ASC30 to Evaluate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes
Key facts
- Where
- Athens, Larissa, Marousi, Palaió Fáliro, Pylaia, and Thessaloniki, GreeceSee the 6 sites
- Phase
- Phase 3
Where in Greece
- AthensAthens, GreeceNot yet recruiting
- LarissaLarissa, GreeceNot yet recruiting
- MarousiMarousi, GreeceNot yet recruiting
- Palaió FáliroPalaió Fáliro, GreeceNot yet recruiting
- PylaiaPylaia, GreeceNot yet recruiting
- ThessalonikiThessaloniki, GreeceNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ascletis Pharma (China) Co., Limited
- Trial code
- NCT07743450
- Record updated
- 16 September 2026
- Original description
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.Read full original descriptionShow less
A Phase III, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Once-Daily Oral ASC30 in Adult Participants With Obesity or Overweight With Type 2 Diabetes Mellitus (AURORA-2)
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.
Inclusion: 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 ≥ 27 kg/m2 at screening; Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight; 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: Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening; Have a history of acute or chronic pancreatitis any time prior to screening; 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; Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM; Have known allergies or intolerance to glucagon-like peptide-1 Receptor Agonists (GLP-1 RA); Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2; Have an estimated glomerular filtration rate (eGFR) < 15 mL/min/1.73 m2, as determined by the laboratory at screening.