Visugromab in Cachexia International Trial

NCT07112196 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CTL-002-006
• Study Type: interventional
• Target: 518
• Locations: 6 countries
• Sites: 7

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 (7)

Mid Florida Hematology and Oncology Centers

Orange City, Florida, 32763, United States

RECRUITING

Specialized Hospital for Active Treatment in Oncology

Haskovo, 6300, Bulgaria

RECRUITING

Léon Bérard Center (Centre Léon Bérard)

Lyon, 69008, France

RECRUITING

Oslo University Hospital

Oslo, 0372, Norway

RECRUITING

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

A Coruña, 15006, Spain

RECRUITING

Cantonal Hospital St. Gallen (Kantonsspital St. Gallen)

Sankt Gallen, 9000, Switzerland

RECRUITING

University Hospital of Zurich (Universitätsspital Zürich)

Zurich, 8006, Switzerland

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: April 23, 2026

Record last verified: 2026-04

Locations

US (1); ES (1); BU (1); CH (2); NO (1); FR (1)