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2026-526336-39-00RecruitingPhase 3

Efficacy and Safety of Once-Daily Oral ASC30 Compared with Placebo in Participants with Obesity or Overweight with Type 2 Diabetes Mellitus

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)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 13 Oct 2026

Next steps

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
549 (estimated)
First submitted
10 Jun 2026
Start date
7 Oct 2026
Lead sponsor
Ascletis Pharma (China) Co. Ltd.
EU CT number
2026-526336-39-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 549
  • 43 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Have Type 1 Diabetes Mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2DM.

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (43)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Pratia Czech s.r.o.PardubiceCzechiaRecruiting
Synexus Czech s.r.o.Praha 2CzechiaRecruiting
Praglandia s.r.o.Praha 5CzechiaRecruiting
Clinical Trials Service s.r.o.Uherské HradištěCzechiaRecruiting
Velocity Clinical Research Germany GmbHBerlinGermanyRecruiting
FutureMeds GmbHBerlinGermanyRecruiting
Dr. med. Bernd Becker Praxis am MarktEssenGermanyRecruiting
Klinische Forschung Hannover-Mitte GmbHHanoverGermanyRecruiting
Areteio HospitalAthensGreeceRecruiting
Evangelismos S AAthensGreeceRecruiting
Thoracic General Hospital of Athens "I Sotiria"AthensGreeceRecruiting
General University Hospital of LarissaLarissaGreeceRecruiting
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.MaroussiGreeceRecruiting
Athens Medical Center S.A.Paleo FaliroGreeceRecruiting
University General Hospital of Thessaloniki - AHEPAThessalonikiGreeceRecruiting
Athens Medical Center S.A.ThessalonikiGreeceRecruiting
Ippokratio General Hospital of ThessalonikiThessalonikiGreeceRecruiting
ETG Biała PodlaskaBiała PodlaskaPolandRecruiting
Centrum Medyczne "Hipokrates" s.c. Elżbieta i Grzegorz GrześkBydgoszczPolandRecruiting
Medyczne Centrum Diabetologiczno-Endokrynologiczno-Metaboliczne Diab-Endo-Met Sp. z o.o.CracowPolandRecruiting
Synexus Polska Sp. z o.o.CzestochowaPolandRecruiting
Synexus Polska Sp z o.o.GdanskPolandRecruiting
Synexus Polska Sp. z o.o.GdyniaPolandRecruiting
FutureMeds GdyniaGdyniaPolandRecruiting
Synexus Polska Sp. z o.o.KatowicePolandRecruiting
FutureMeds KrakowKrakowPolandRecruiting
Synexus Polska Sp. z o.o.LodzPolandRecruiting
FutureMeds ŁódźŁódźPolandRecruiting
Velocity Nova Sp. z o.o.LublinPolandRecruiting
Clinical Best Solutions Sp. z o.o., Sp. K.LublinPolandRecruiting
Synexus Polska Sp z o oPoznanPolandRecruiting
Twoja Przychodnia PCMPoznanPolandRecruiting
Velocity Nova Sp. z o.o.PulawyPolandRecruiting
Lukmed 2 Sp. z o.o.SiedlcePolandRecruiting
Velocity Nova Sp. z o.o.StaszowPolandRecruiting
Mics Centrum Medyczne TorunTorunPolandRecruiting
Synexus Polska Sp. z o.o.WarsawPolandRecruiting
Centrum medyczne Justmed Sp. z o.o.WarsawPolandRecruiting
Clinical Best Solutions Sp. Z O.O. Sp.K.WarsawPolandRecruiting
Futuremeds TargówekWarszawaPolandRecruiting
FutureMeds Warszawa CentrumWarszawaPolandRecruiting
Synexus Polska Sp. z o.o.WroclawPolandRecruiting
FutureMeds WrocławWrocławPolandRecruiting

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This page is information, not medical advice. Discuss any trial with your doctor.