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2026-526172-23-00RecruitingPhase 3

Efficacy and Safety of Once-Daily Oral ASC30 Compared with Placebo in Participants with Obesity or Overweight with Weight-Related Comorbidities

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)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 29 Oct 2026

Next steps

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
932 (estimated)
First submitted
10 Jun 2026
Start date
7 Oct 2026
Lead sponsor
Ascletis Pharma (China) Co. Ltd.
Diseases
Obesity
EU CT number
2026-526172-23-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 932
  • 44 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 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.

Other illness

  • Participants with a personal or family (first-degree relative) history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia (MEN) syndrome type 2. "

Who the study is looking for

  • 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.

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (44)

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
Praxis Am MarktEssenGermanyRecruiting
Klinische Forschung Hannover-Mitte GmbHHanoverGermanyRecruiting
Ambenet GmbH Das Ambulante BehandlungsnetzLeipzigGermanyRecruiting
Thoracic General Hospital of Athens "I Sotiria"AthensGreeceRecruiting
Evangelismos S AAthensGreeceRecruiting
Areteio HospitalAthensGreeceRecruiting
General University Hospital of LarissaLarissaGreeceRecruiting
Diagnostic & Therapeutic Center Of Athens Hygeia Single Member S.A.MaroussiGreeceRecruiting
Athens Medical Center S.A.Paleo FaliroGreeceRecruiting
Ippokratio General Hospital of ThessalonikiThessalonikiGreeceRecruiting
University General Hospital of Thessaloniki - AHEPAThessalonikiGreeceRecruiting
Athens Medical Center S.A.ThessalonikiGreeceRecruiting
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
Clinical Best Solutions Sp. z o.o., Sp. K.LublinPolandRecruiting
Velocity Nova Sp. z o.o.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
Clinical Best Solutions Sp. Z O.O. Sp.K.WarsawPolandRecruiting
Centrum medyczne Justmed Sp. z o.o.WarsawPolandRecruiting
Synexus Polska Sp. z o.o.WarsawPolandRecruiting
FutureMeds Warszawa CentrumWarszawaPolandRecruiting
Futuremeds TargówekWarszawaPolandRecruiting
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.