Cancer-associated CachexiaPhase 2/3VINCITNCT07112196
Visugromab in Cachexia International Trial
A Phase 2/3 study testing Visugromab (CTL-002) in people with Cancer-associated Cachexia, run by CatalYm GmbH at 74 sites in 12 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer-associated Cachexia
- What is being tested?
- Visugromab (CTL-002)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 518 participants
- Where
- 74 sitesin 12 countries
- Study dates
- 16 Apr 2026to Dec 2030
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Weight loss
- Advanced cancer
Who cannot join
- 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
Trial locations and contacts
74 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
74 sites in 12 countries
Poland11 sites, 11 recruiting
- Recruiting
Pratia Onkologia Katowice
Katowice, 40-519
- Recruiting
Jagiellońskie Centrum Innowacji Sp. z o.o.
Krakow, 30-348
- Recruiting
Pratia MCM Kraków
Krakow, 30-727
- Recruiting
FutureMeds Krakow
Krakow, 31-501
- Recruiting
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, 31-826
- Recruiting
Futuremeds Łódź
Lodz, 91-363
- Recruiting
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi.
Lodz, 93-513
- Recruiting
MS CLINSEARCH Specjalistyczny NZOZ Janusz Milanowski, Katarzyna Szmygin - Milanowska Sp. j.
Lublin, 20-064
- Recruiting
FutureMeds Targówek
Warsaw, 03-505
- Recruiting
Pratia Onkologia Wrocław
Wroclaw, 50-019
- Recruiting
FutureMeds Sp.zo.o - FutureMeds Wrocław
Wroclaw, 53-673
United States10 sites, 10 recruiting
- Recruiting
Augusta University Medical Center
Augusta, Georgia, 30912
- Recruiting
Cleveland Clinic Avon Hospital
Avon, Ohio, 44011
- Recruiting
Clermont Oncology Center
Clermont, Florida, 34711
- Recruiting
Cleveland Clinic (Main Campus)
Cleveland, Ohio, 44195
- Recruiting
Astera Cancer Care
East Brunswick, New Jersey, 08816
- Recruiting
Cleveland Clinic Fairview Hospital
Fairview, Ohio, 44111
- Recruiting
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, 44124
- Recruiting
Eastern Connecticut Hematology & Oncology
Norwich, Connecticut, 06360
- Recruiting
Mid Florida Hematology and Oncology Centers
Orange City, Florida, 32763
- Recruiting
Cleveland Clinic Martin Health
Stuart, Florida, 34994
Romania8 sites, 8 recruiting
- Recruiting
Futuremeds Romania Brasov
Brasov, 500052
- Recruiting
Oncolab Craiova
Craiova, 200385
- Recruiting
St. Nectarie Oncology Center, Craiova
Craiova, 200801
- Recruiting
Futuremeds Romania Galati
Galati, 800001
- Recruiting
Spitalul Pelican Oradea
Oradea, 410450
- Recruiting
Ovidius Clinical Hospital
Ovidiu, 905900
- Recruiting
Gral Medical - Oncofort Hospital Pitesti
Piteşti, 110283
- Recruiting
Oncomed S.R.L.
Timișoara, 300239
United Kingdom7 sites, 7 recruiting
- Recruiting
Royal Sussex County Hospital
Brighton, BN2 5BE
- Recruiting
Addenbrooke's Hospital
Cambridge, CB2 0RE
- Recruiting
Ninewells Hospital
Dundee, DD2 1SG
- Recruiting
Western General Hospital
Edinburgh, EH4 2XU
- Recruiting
Royal Surrey County Hospital
Guildford, GU2 7XX
- Recruiting
The Christie
Manchester, M20 4BX
- Recruiting
Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Switzerland6 sites, 6 recruiting
- Recruiting
Tumor Zentrum Aarau
Aarau, 5000
- Recruiting
Universitaetsspital Basel
Basel, 4031
- Recruiting
Istituto Oncologico della Svizzera Italiana
Bellinzona, 6500
- Recruiting
Gruppo Ospedaliero Moncucco - Clinica Moncucco
Lugano, 6900
- Recruiting
Cantonal Hospital St. Gallen (Kantonsspital St. Gallen)
Sankt Gallen, 9000
- Recruiting
University Hospital of Zurich (Universitätsspital Zürich)
Zurich, 8006
Czechia5 sites, 5 recruiting
- Recruiting
Multiscan, s.r.o., Nemocnice Horovice
Hořovice, 268 01
- Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05
- Recruiting
Fakultni nemocnice Olomouc
Olomouc, 775 00
- Recruiting
Vseobecna fakultni nemocnice v Praze
Prague, 12808
- Recruiting
Fakultni nemocnice v Motole
Prague, 15006
France5 sites, 5 recruiting
- Recruiting
CHRU de Brest - Hopital Morvan
Brest, 29200
- Recruiting
AP-HP Hôpital Henri Mondor
Créteil, 94010
- Recruiting
Léon Bérard Center (Centre Léon Bérard)
Lyon, 69008
- Recruiting
HCL Centre Hospitalier Lyon Sud
Lyon, 69495
- Recruiting
Centre Paul Strauss
Strasbourg, 67200
Italy5 sites, 5 recruiting
- Recruiting
Centro Riferimento Oncologico - Aviano
Aviano, 33081
- Recruiting
ASST degli Spedali Civili di Brescia
Brescia, 25123
- Recruiting
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
Ferrara, 44124
- Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.
Meldola, 47014
- Recruiting
Centro Ricerche Cliniche di Verona
Verona, 37134
Norway5 sites, 5 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5009
- Recruiting
Sorlandet sykehus HF - Kristiansand
Kristiansand, 4615
- Recruiting
Oslo University Hospital
Oslo, 0372
- Recruiting
Akershus University Hospital
Oslo, 1478
- Recruiting
St. Olavs hospital HF, Universitetssykehuset i Trondheim
Trondheim, 7030
Bulgaria4 sites, 4 recruiting
- Recruiting
Specialized Hospital for Active Treatment in Oncology
Haskovo, 6300
- Recruiting
Medical Centre Futuremeds Plovdiv
Plovdiv, 4000
- Recruiting
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL
Sofia, 1527
- Recruiting
Complex Oncology Center - Vratsa EOOD
Vratsa, 3001
Germany4 sites, 4 recruiting
- Recruiting
Johanniter Krankenhaus Bonn
Bonn, 53113
- Recruiting
University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dresden)
Dresden, 01307
- Recruiting
LungenClinic Grosshansdorf GmbH
Großhansdorf, 22927
- Recruiting
Muenchen Klinik Neuperlach
München, 81737
Spain4 sites, 4 recruiting
- Recruiting
University Hospital of A Coruña (Hospital Universitario de A Coruña)
A Coruña, 15006
- Recruiting
Hospital Clinic Barcelona
Barcelona, 08036
- Recruiting
Futuremeds Hospital Viamed Santa Elena
Madrid, 28003
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda, 28222
About this study
Official title: Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia
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.
- Conditions
- Cancer-associated Cachexia
- Being tested
- Visugromab (CTL-002), Placebo
- Keywords
- Cachexia, Cancer, Weight loss, Wasting, Anorexia
- Medical subject headings
- Cachexia, Neoplasms, Weight Loss, Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visugromab (CTL-002)Drug
High dose
PlaceboDrug
IV infusion
Visugromab (CTL-002)Drug
Medium dose
Visugromab (CTL-002)Drug
Low dose
| Study group | Role | What they receive |
|---|---|---|
| Visugromab low dose | Active comparator | Not described Receives: Drug: Visugromab (CTL-002) |
| Visugromab medium dose | Active comparator | Not described Receives: Drug: Visugromab (CTL-002) |
| Visugromab high dose | Active comparator | Not described Receives: Drug: Visugromab (CTL-002) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in body weight at 12 weeks
Measured: 12 weeks
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)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start16 Apr 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer-associated CachexiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 518 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CatalYm GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07112196
- Sponsor's protocol ID
- CTL-002-006
- Acronym
- VINCIT
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive, Phase 2/3, Randomized, Double-Blind Trial Investigating the Efficacy and Safety of Visugromab Versus Placebo in Patients With Cancer-associated Cachexia
- ClinicalTrials.gov ID
- NCT07112196
- Acronym / sponsor ID
- VINCIT / CTL-002-006
- Conditions
- Cancer-associated Cachexia
- Keywords
- Cachexia, Cancer, Weight loss, Wasting, Anorexia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 518 participants (estimated)
- Lead sponsor
- CatalYm GmbHIndustry (pharma, biotech, devices)
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 8 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Visugromab low dose | Active comparator | Drug: Visugromab (CTL-002) |
| Visugromab medium dose | Active comparator | Drug: Visugromab (CTL-002) |
| Visugromab high dose | Active comparator | Drug: Visugromab (CTL-002) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Weight loss
- Advanced cancer
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visugromab (CTL-002)High dose | Drug | Visugromab high dose |
| PlaceboIV infusion | Drug | Placebo |
| Visugromab (CTL-002)Medium dose | Drug | Visugromab medium dose |
| Visugromab (CTL-002)Low dose | Drug | Visugromab low dose |
Primary outcome
Change from baseline in body weight at 12 weeks
Time frame: 12 weeks
Change from baseline in appetite at 12 weeks
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
Related trials for Cancer-associated Cachexia
Not yet recruitingPhase 1
A Study to Learn About the Study Medicine Called Ponsegromab in Adults With Lung Cancer-Associated Significant Body Weight Loss
Non-small Cell Lung Cancer (NSCLC), Cachexia
RecruitingPhase 2
Olanzapine for the Management of Cancer Associated Appetite Loss in Patients With Advanced Esophagogastric, Hepatopancreaticobiliary, Colorectal or Lung Cancer
Advanced Malignant Solid Neoplasm, Advanced Biliary Tract Carcinoma
Active, not recruitingObservational study
Cancer-associated Cachexia in Patients With Incurable Gastroesophageal Cancer
Gastro-Esophageal Cancer
Recruiting
Study on the Pathogenesis and Reversal Strategies of Cancer Cachexia Based on Multi-Omics
Cachexia; Cancer; Sarcopenia
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
74 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Visugromab (CTL-002) in people with Cancer-associated Cachexia, run by CatalYm GmbH at 74 sites in 12 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 74 sites in Poland, United States, Romania, United Kingdom, Switzerland and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Director (49 8920006640, regulatory-006@catalym.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in body weight at 12 weeks (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.