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RecruitingNCT07112196VINCITUpdated Sep 22, 2026

Visugromab in Cachexia International Trial

A Phase 2/3 interventional study of Visugromab (CTL-002) and Placebo in Cancer-associated Cachexia, sponsored by CatalYm GmbH. Recruiting at 74 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-22.

Sponsored by CatalYm GmbH · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
518
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

A study of how well and safely a new drug called visugromab works in people with certain kinds of cancer (including lung and bowel cancer) and unintended weight loss known as cachexia. The main questions it aims to answer are:

  • Does visugromab help participants put weight back on and have a better appetite?
  • Does visugromab help participants move more and better?
  • What medical problems do participants have when taking visugromab? Researchers will compare visugromab to a placebo (a look-alike substance that contains no drug).

Participants will visit the hospital or clinic once every 4 weeks to receive visugromab or placebo via a drip into a vein and to undergo checkups and tests.

02

Conditions studied

  • Cancer-associated Cachexia

Keywords

  • Cachexia
  • Cancer
  • Weight loss
  • Wasting
  • Anorexia
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Weight loss
  • Advanced cancer

Exclusion criteria

Exclusion Criteria:

  • Participation in another interventional clinical trial, receipt of any investigational therapy or use of any investigational device within 4 weeks prior to screening and between screening and the first dose of investigational product
04

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
518 participants (estimated)

Study arms

  • Active comparator
    Visugromab low dose

    Drug: Visugromab (CTL-002)

  • Active comparator
    Visugromab medium dose

    Drug: Visugromab (CTL-002)

  • Active comparator
    Visugromab high dose

    Drug: Visugromab (CTL-002)

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugVisugromab (CTL-002)

    High dose

  • DrugPlacebo

    IV infusion

  • DrugVisugromab (CTL-002)

    Medium dose

  • DrugVisugromab (CTL-002)

    Low dose

05

What researchers measure

Primary outcomes

  1. Change from baseline in body weight at 12 weeks

    Time frame: 12 weeks

  2. Change from baseline in appetite at 12 weeks

    Measured on the 5-item anorexia subscale of the Functional Assessment of Anorexia/Cachexia Therapy instrument (minimum score 0, maximum 20; higher is better outcome)

    Time frame: 12 weeks

06

Study locations

74 of 74 sites recruiting
  • Eastern Connecticut Hematology & Oncology
    Norwich, Connecticut 06360, United States
    Recruiting
  • Clermont Oncology Center
    Clermont, Florida 34711, United States
    Recruiting
  • Mid Florida Hematology and Oncology Centers
    Orange City, Florida 32763, United States
    Recruiting
  • Cleveland Clinic Martin Health
    Stuart, Florida 34994, United States
    Recruiting
  • Augusta University Medical Center
    Augusta, Georgia 30912, United States
    Recruiting
  • Astera Cancer Care
    East Brunswick, New Jersey 08816, United States
    Recruiting
  • Cleveland Clinic Avon Hospital
    Avon, Ohio 44011, United States
    Recruiting
  • Cleveland Clinic (Main Campus)
    Cleveland, Ohio 44195, United States
    Recruiting
  • Cleveland Clinic Fairview Hospital
    Fairview, Ohio 44111, United States
    Recruiting
  • Cleveland Clinic Hillcrest Hospital
    Mayfield Heights, Ohio 44124, United States
    Recruiting
  • Specialized Hospital for Active Treatment in Oncology
    Haskovo, 6300, Bulgaria
    Recruiting
  • Medical Centre Futuremeds Plovdiv
    Plovdiv, 4000, Bulgaria
    Recruiting
  • University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL
    Sofia, 1527, Bulgaria
    Recruiting
  • Complex Oncology Center - Vratsa EOOD
    Vratsa, 3001, Bulgaria
    Recruiting
  • Multiscan, s.r.o., Nemocnice Horovice
    Hořovice, 268 01, Czechia
    Recruiting
  • Fakultni nemocnice Hradec Kralove
    Hradec Králové, 500 05, Czechia
    Recruiting
  • Fakultni nemocnice Olomouc
    Olomouc, 775 00, Czechia
    Recruiting
  • Vseobecna fakultni nemocnice v Praze
    Prague, 12808, Czechia
    Recruiting
  • Fakultni nemocnice v Motole
    Prague, 15006, Czechia
    Recruiting
  • CHRU de Brest - Hopital Morvan
    Brest, 29200, France
    Recruiting
  • AP-HP Hôpital Henri Mondor
    Créteil, 94010, France
    Recruiting
  • Léon Bérard Center (Centre Léon Bérard)
    Lyon, 69008, France
    Recruiting
  • HCL Centre Hospitalier Lyon Sud
    Lyon, 69495, France
    Recruiting
  • Centre Paul Strauss
    Strasbourg, 67200, France
    Recruiting
  • Johanniter Krankenhaus Bonn
    Bonn, 53113, Germany
    Recruiting
  • University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dresden)
    Dresden, 01307, Germany
    Recruiting
  • LungenClinic Grosshansdorf GmbH
    Großhansdorf, 22927, Germany
    Recruiting
  • Muenchen Klinik Neuperlach
    München, 81737, Germany
    Recruiting
  • Centro Riferimento Oncologico - Aviano
    Aviano, 33081, Italy
    Recruiting
  • ASST degli Spedali Civili di Brescia
    Brescia, 25123, Italy
    Recruiting
  • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
    Ferrara, 44124, Italy
    Recruiting
  • IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.
    Meldola, 47014, Italy
    Recruiting
  • Centro Ricerche Cliniche di Verona
    Verona, 37134, Italy
    Recruiting
  • Haukeland University Hospital
    Bergen, 5009, Norway
    Recruiting
  • Sorlandet sykehus HF - Kristiansand
    Kristiansand, 4615, Norway
    Recruiting
  • Oslo University Hospital
    Oslo, 0372, Norway
    Recruiting
  • Akershus University Hospital
    Oslo, 1478, Norway
    Recruiting
  • St. Olavs hospital HF, Universitetssykehuset i Trondheim
    Trondheim, 7030, Norway
    Recruiting
  • Pratia Onkologia Katowice
    Katowice, 40-519, Poland
    Recruiting
  • Jagiellońskie Centrum Innowacji Sp. z o.o.
    Krakow, 30-348, Poland
    Recruiting
  • Pratia MCM Kraków
    Krakow, 30-727, Poland
    Recruiting
  • FutureMeds Krakow
    Krakow, 31-501, Poland
    Recruiting
  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
    Krakow, 31-826, Poland
    Recruiting
  • Futuremeds Łódź
    Lodz, 91-363, Poland
    Recruiting
  • Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi.
    Lodz, 93-513, Poland
    Recruiting
  • MS CLINSEARCH Specjalistyczny NZOZ Janusz Milanowski, Katarzyna Szmygin - Milanowska Sp. j.
    Lublin, 20-064, Poland
    Recruiting
  • FutureMeds Targówek
    Warsaw, 03-505, Poland
    Recruiting
  • Pratia Onkologia Wrocław
    Wroclaw, 50-019, Poland
    Recruiting
  • FutureMeds Sp.zo.o - FutureMeds Wrocław
    Wroclaw, 53-673, Poland
    Recruiting
  • Futuremeds Romania Brasov
    Brasov, 500052, Romania
    Recruiting
  • Oncolab Craiova
    Craiova, 200385, Romania
    Recruiting
  • St. Nectarie Oncology Center, Craiova
    Craiova, 200801, Romania
    Recruiting
  • Futuremeds Romania Galati
    Galati, 800001, Romania
    Recruiting
  • Spitalul Pelican Oradea
    Oradea, 410450, Romania
    Recruiting
  • Ovidius Clinical Hospital
    Ovidiu, 905900, Romania
    Recruiting
  • Gral Medical - Oncofort Hospital Pitesti
    Piteşti, 110283, Romania
    Recruiting
  • Oncomed S.R.L.
    Timișoara, 300239, Romania
    Recruiting
  • University Hospital of A Coruña (Hospital Universitario de A Coruña)
    A Coruña, 15006, Spain
    Recruiting
  • Hospital Clinic Barcelona
    Barcelona, 08036, Spain
    Recruiting
  • Futuremeds Hospital Viamed Santa Elena
    Madrid, 28003, Spain
    Recruiting
  • Hospital Universitario Puerta de Hierro
    Majadahonda, 28222, Spain
    Recruiting
  • Tumor Zentrum Aarau
    Aarau, 5000, Switzerland
    Recruiting
  • Universitaetsspital Basel
    Basel, 4031, Switzerland
    Recruiting
  • Istituto Oncologico della Svizzera Italiana
    Bellinzona, 6500, Switzerland
    Recruiting
  • Gruppo Ospedaliero Moncucco - Clinica Moncucco
    Lugano, 6900, Switzerland
    Recruiting
  • Cantonal Hospital St. Gallen (Kantonsspital St. Gallen)
    Sankt Gallen, 9000, Switzerland
    Recruiting
  • University Hospital of Zurich (Universitätsspital Zürich)
    Zurich, 8006, Switzerland
    Recruiting
  • Royal Sussex County Hospital
    Brighton, BN2 5BE, United Kingdom
    Recruiting
  • Addenbrooke's Hospital
    Cambridge, CB2 0RE, United Kingdom
    Recruiting
  • Ninewells Hospital
    Dundee, DD2 1SG, United Kingdom
    Recruiting
  • Western General Hospital
    Edinburgh, EH4 2XU, United Kingdom
    Recruiting
  • Royal Surrey County Hospital
    Guildford, GU2 7XX, United Kingdom
    Recruiting
  • The Christie
    Manchester, M20 4BX, United Kingdom
    Recruiting
  • Freeman Hospital
    Newcastle upon Tyne, NE7 7DN, United Kingdom
    Recruiting
07

Registry details

Key details

Study ID
NCT07112196
Lead sponsor
CatalYm GmbH
Responsible party
Sponsor
First posted
Aug 8, 2025
Start date
Apr 16, 2026
Primary completion
Dec 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Sep 22, 2026

Study contacts

Trial Director
Contact
regulatory-006@catalym.com
49 8920006640

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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