Efficacy and Safety of Once-Daily Oral ASC30 Compared with Placebo in Participants with Obesity or Overweight with Weight-Related Comorbidities
Key facts
- Where
- Biała Podlaska, Bydgoszcz, Cracow, Czestochowa, Gdansk, Gdynia, Katowice, Krakow, Lodz, Łódź, Lublin, Poznan, Pulawy, Siedlce, Staszow, Torun, Warsaw, Warszawa, Wroclaw és Wrocław, LengyelországSee the 26 sites
- Phase
- 3. fázis
Where in Lengyelország
- ETG Biała PodlaskaBiała Podlaska, LengyelországTaking people
- Centrum Medyczne "Hipokrates" s.c. Elżbieta i Grzegorz GrześkBydgoszcz, LengyelországTaking people
- Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.Cracow, LengyelországTaking people
- Synexus Polska Sp. z o.o.Czestochowa, LengyelországTaking people
- Synexus Polska Sp z o.o.Gdansk, LengyelországTaking people
- FutureMeds GdyniaGdynia, LengyelországTaking people
- Synexus Polska Sp. z o.o.Gdynia, LengyelországTaking people
- Synexus Polska Sp. z o.o.Katowice, LengyelországTaking people
- FutureMeds KrakowKrakow, LengyelországTaking people
- Synexus Polska Sp. z o.o.Lodz, LengyelországTaking people
- FutureMeds ŁódźŁódź, LengyelországTaking people
- Clinical Best Solutions Sp. z o.o., Sp. K.Lublin, LengyelországTaking people
- Velocity Nova Sp. z o.o.Lublin, LengyelországTaking people
- Synexus Polska Sp z o oPoznan, LengyelországTaking people
- Twoja Przychodnia PCMPoznan, LengyelországTaking people
- Velocity Nova Sp. z o.o.Pulawy, LengyelországTaking people
- Lukmed 2 Sp. z o.o.Siedlce, LengyelországTaking people
- Velocity Nova Sp. z o.o.Staszow, LengyelországTaking people
- Mics Centrum Medyczne TorunTorun, LengyelországTaking people
- Centrum medyczne Justmed Sp. z o.o.Warsaw, LengyelországTaking people
- Clinical Best Solutions Sp. Z O.O. Sp.K.Warsaw, LengyelországTaking people
- Synexus Polska Sp. z o.o.Warsaw, LengyelországTaking people
- Futuremeds TargówekWarszawa, LengyelországTaking people
- FutureMeds Warszawa CentrumWarszawa, LengyelországTaking people
- Synexus Polska Sp. z o.o.Wroclaw, LengyelországTaking people
- FutureMeds WrocławWrocław, LengyelországTaking people
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. Ltd.
- Trial code
- EU 2026-526172-23-00
- Record updated
- 2026. október 29.
- Original description
To demonstrate that dose 1 , dose 2 , and/or dose 3 pooled doses of once-daily oral ASC30 is superior to placebo From baseline to Week 72 in: Body weightRead 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 Weight-Related Comorbidities (AURORA-1)
To demonstrate that dose 1 , dose 2 , and/or dose 3 pooled doses of once-daily oral ASC30 is superior to placebo From baseline to Week 72 in: Body weight
Inclusion: 1-Be able to provide signed informed consent and comply with study requirements; 2-Be ≥18 years old (or legal age of consent locally); 3-Have: BMI ≥30 kg/m², or 4-BMI ≥27 kg/m² with at least one weight-related comorbidity such as: cardiovascular disease, hypertension, dyslipidemia, or obstructive sleep apnea; 5-Have at least one prior unsuccessful dietary weight-loss attempt; 6-Not be pregnant or breastfeeding; contraception requirements apply per local regulations.
Exclusion: 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; 2.Have a history of acute or chronic pancreatitis any time prior to screening; Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2. ".