Visugromab in Cachexia International Trial

NCT07112196 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CTL-002-006
• Study Type: interventional
• Target: 518
• Locations: 12 countries
• Sites: 56

Brief 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.

Conditions

Cancer-associated Cachexia

Keywords

Cachexia; Cancer; Weight loss; Wasting; Anorexia

Outcome Measures

Primary Outcomes (2)

• Change from baseline in body weight at 12 weeks

  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)

  12 weeks

Study Arms (4)

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

Interventions

Visugromab (CTL-002) DRUG

High dose

Visugromab high dose

Placebo DRUG

IV infusion

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight loss
• Advanced cancer

You may not qualify if:

• 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

Sponsors & Collaborators

• CatalYm GmbH: lead

Study Sites (56)

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

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 v Motole

Prague, 15006, Czechia

RECRUITING

CHRU de Brest - Hopital Morvan

Brest, 29200, France

RECRUITING

Léon Bérard Center (Centre Léon Bérard)

Lyon, 69008, 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

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

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

Gral Medical - Oncofort Hospital Pitesti

Piteşti, 110283, Romania

RECRUITING

University Hospital of A Coruña (Hospital Universitario de A Coruña)

A Coruña, 15006, Spain

RECRUITING

Futuremeds Hospital Viamed Santa Elena

Madrid, 28003, Spain

RECRUITING

Hospital Universitario Puerta de Hierro

Majadahonda, 28222, Spain

NOT YET RECRUITING

Tumor Zentrum Aarau

Aarau, 5000, 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

Ninewells Hospital

Dundee, DD2 1SG, United Kingdom

RECRUITING

Royal Surrey County Hospital

Guildford, GU2 7XX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cachexia; Neoplasms; Weight Loss; Anorexia

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness; Signs and Symptoms, Digestive

Central Study Contacts

Trial Director

CONTACT

49 8920006640; regulatory-006@catalym.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2025
• First Posted: August 8, 2025
• Study Start: April 16, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: July 21, 2026

Record last verified: 2026-07

Locations

US (8); ES (3); BU (4); CH (4); FR (3); GB (3); RO (6); DE (2); CZ (3); PL (10); IT (5); NO (5)