Efficacy and Safety of Once-Daily Oral ASC30 Compared with Placebo in Participants with Obesity or Overweight with Type 2 Diabetes Mellitus
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 2026-526336-39-00
- Record updated
- 2026. október 13.
- Original description
To demonstrate that dose 1, dose 2, and/or dose 3 once-daily oral ASC30 is superior to placebo for body weight at 72 weeks.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)
To demonstrate that dose 1, dose 2, and/or dose 3 once-daily oral ASC30 is superior to placebo for body weight at 72 weeks.
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; Are on stable treatment for T2DM for at least 90 days prior to screening, consisting of: - either diet/exercise alone, or - up to 3 oral antihyperglycemic medications (AHMs) (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like-peptide-1 (GLP-1) receptor agonists (RA), GLP-1R/GIPR dual agonists, GLP-1R/GIPR/GCGR triple agonists, amylin receptor agonists or GLP-1 receptor and amylin receptor dual agonists).
Exclusion: Have a prior or planned surgical treatment for obesity (excluding Liposuction, Abdominoplasty, or Cryolipolysis, if performed >1 year prior to screening); Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema (for example, laser photocoagulation or intravitreal injections of antivascular endothelial growth factor inhibitors). Note: all participants will have a baseline fundus photography assessment. In the presence of any degree of diabetic retinopathy and/or macular edema, further ophthalmologic assessment will be performed to confirm eligibility; Have a self-reported change in body weight >5 kg (11 pounds) within 3 months prior to screening; Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.