Visugromab for cancer-related wasting and unintended weight loss
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
Run by CatalYm GmbH · NCT07112196 · Data updated 2026-11-12
This trial will test whether visugromab helps people with advanced cancer and unintentional weight loss (cachexia) gain weight, have a better appetite, and improve mobility compared with a placebo.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 518 (estimated) |
| Sponsor | CatalYm GmbH Industry-sponsored |
| Drugs / interventions | visugromab |
| Locations | 79 sites (Norwich, Connecticut and 78 other locations) |
| Status | Recruiting |
| Started | April 16, 2026 |
| Main results expected | December 2029 |
| Study ends | December 2030 |
| Registry record updated | November 2, 2026 |
| Trial ID | NCT07112196 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with advanced cancer who have unintentional weight loss consistent with cachexia (including patients with lung or bowel cancers) and who meet the study's medical criteria are the intended participants.
✕Probably not a fit
Patients without cancer-associated unintentional weight loss, those currently enrolled in another interventional investigational trial within the prohibited window, or those unable to receive IV infusions are unlikely to benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase 2/3 interventional trial compares the investigational drug visugromab to a placebo in people with cancer-associated cachexia. Participants are assigned to receive visugromab or placebo by intravenous infusion once every four weeks and return for regular checkups and tests. Key outcomes include changes in body weight, appetite, physical activity and function, and monitoring of side effects and safety. The study is conducted at multiple international centers and follows participants over repeated monthly visits.
Why it matters
Potential benefit: If successful, visugromab could help people with cancer-associated cachexia regain weight, improve appetite, and increase physical function.
How similar studies have gone: Treatments for cancer cachexia to date have had mixed results, so visugromab represents a newer approach that is still being tested in larger trials.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Weight loss * Advanced cancer 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
Where it's running
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Eastern Connecticut Hematology & Oncology
Norwich, Connecticut, United States Recruiting -
Clermont Oncology Center
Clermont, Florida, United States Recruiting -
Mid Florida Hematology and Oncology Centers
Orange City, Florida, United States Recruiting -
Cleveland Clinic Martin Health
Stuart, Florida, United States Recruiting -
Cleveland Clinic Weston Hospital
Weston, Florida, United States Recruiting -
Augusta University Medical Center
Augusta, Georgia, United States Recruiting
Show 44 more locations
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Astera Cancer Care
East Brunswick, New Jersey, United States Recruiting -
Cleveland Clinic Avon Hospital
Avon, Ohio, United States Recruiting -
Cleveland Clinic (Main Campus)
Cleveland, Ohio, United States Recruiting -
Cleveland Clinic Fairview Hospital
Fairview, Ohio, United States Recruiting -
Cleveland Clinic Hillcrest Hospital
Mayfield Heights, Ohio, United States Recruiting -
Specialized Hospital for Active Treatment in Oncology
Haskovo, Bulgaria Recruiting -
Medical Centre Futuremeds Plovdiv
Plovdiv, Bulgaria Recruiting -
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna-ISUL
Sofia, Bulgaria Recruiting -
Complex Oncology Center - Vratsa EOOD
Vratsa, Bulgaria Recruiting -
Multiscan, s.r.o., Nemocnice Horovice
Hořovice, Czechia Recruiting -
Fakultni nemocnice Hradec Kralove
Hradec Králové, Czechia Recruiting -
Fakultni nemocnice Olomouc
Olomouc, Czechia Recruiting -
Vseobecna fakultni nemocnice v Praze
Prague, Czechia Recruiting -
Fakultni nemocnice v Motole
Prague, Czechia Recruiting -
CHRU de Brest - Hopital Morvan
Brest, France Recruiting -
AP-HP Hôpital Henri Mondor
Créteil, France Recruiting -
Léon Bérard Center (Centre Léon Bérard)
Lyon, France Recruiting -
HCL Centre Hospitalier Lyon Sud
Lyon, France Recruiting -
AP-HP Hopital Cochin
Paris, France Recruiting -
Centre Paul Strauss
Strasbourg, France Recruiting -
Johanniter Krankenhaus Bonn
Bonn, Germany Recruiting -
University Hospital Carl Gustav Carus Dresden (Universitätsklinikum Carl Gustav Carus Dresden)
Dresden, Germany Recruiting -
LungenClinic Grosshansdorf GmbH
Großhansdorf, Germany Recruiting -
Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz
Mainz, Germany Recruiting -
Muenchen Klinik Neuperlach
München, Germany Recruiting -
St Vincent's University Hospital
Dublin, Ireland Recruiting -
Centro Riferimento Oncologico - Aviano
Aviano, Italy Recruiting -
ASST degli Spedali Civili di Brescia
Brescia, Italy Recruiting -
Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant'Anna
Ferrara, Italy Recruiting -
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori - IRST S.r.l.
Meldola, Italy Recruiting -
Centro Ricerche Cliniche di Verona
Verona, Italy Recruiting -
Dijklander Ziekenhuis - Locatie Hoorn
Hoorn, Netherlands Recruiting -
Haukeland University Hospital
Bergen, Norway Recruiting -
Sorlandet sykehus HF - Kristiansand
Kristiansand, Norway Recruiting -
Oslo University Hospital
Oslo, Norway Recruiting -
Akershus University Hospital
Oslo, Norway Recruiting -
St. Olavs hospital HF, Universitetssykehuset i Trondheim
Trondheim, Norway Recruiting -
Pratia Onkologia Katowice
Katowice, Poland Recruiting -
Jagiellońskie Centrum Innowacji Sp. z o.o.
Krakow, Poland Recruiting -
Pratia MCM Kraków
Krakow, Poland Recruiting -
FutureMeds Krakow
Krakow, Poland Recruiting -
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Poland Recruiting -
Futuremeds Łódź
Lodz, Poland Recruiting -
Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi.
Lodz, Poland Recruiting
+29 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial Director
- Email: regulatory-006@catalym.com
- Phone: 49 8920006640
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Other studies for the same condition or treatment. Recruiting studies are listed first.
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Visugromab plus nivolumab, with or without docetaxel, for second-line treatment of metastatic non-squamous non-small cell lung cancer
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-
Visugromab plus Nivolumab and Lenvatinib versus Placebo plus Lenvatinib for unresectable or metastatic hepatocellular carcinoma after anti–PD-(L)1 therapy
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Visugromab added to first-line immunochemotherapy for metastatic non-squamous NSCLC
This trial tests whether adding visugromab to standard immunochemotherapy (pembrolizumab, pemetrexed, carboplatin) helps people with newly diagnosed metastatic non-squamous NSCLC who do not have targetable mutations.
-
First-in-human test of QLS2319 in healthy adults and cancer cachexia
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.