Recruiting
Phase 2
Phase 3

Visugromab

Sponsor:

CatalYm GmbH

Code:

NCT07112196

Conditions

Cancer-associated Cachexia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Visugromab (CTL-002)

Placebo

Visugromab (CTL-002)

Visugromab (CTL-002)

Study Details

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

Study ID

NCT07112196

Start date

Apr 16, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

518 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Visugromab low dose

active comparator: Visugromab medium dose

active comparator: Visugromab high dose

placebo comparator: Placebo

Interventions

Visugromab (CTL-002)

High dose

Placebo

IV infusion

Visugromab (CTL-002)

Medium dose

Visugromab (CTL-002)

Low dose

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Trial Director

49 8920006640regulatory-006@catalym.com

Locations

Eastern Connecticut Hematology & Oncology

Recruiting

Norwich, Connecticut, United States, 06360

Clermont Oncology Center

Recruiting

Clermont, Florida, United States, 34711

Mid Florida Hematology and Oncology Centers

Recruiting

Orange City, Florida, United States, 32763

Cleveland Clinic Martin Health

Recruiting

Stuart, Florida, United States, 34994

Augusta University Medical Center

Recruiting

Augusta, Georgia, United States, 30912

Astera Cancer Care

Recruiting

East Brunswick, New Jersey, United States, 08816

Cleveland Clinic Avon Hospital

Recruiting

Avon, Ohio, United States, 44011

Cleveland Clinic (Main Campus)

Recruiting

Cleveland, Ohio, United States, 44195

Cleveland Clinic Fairview Hospital

Recruiting

Fairview, Ohio, United States, 44111

Cleveland Clinic Hillcrest Hospital

Recruiting

Mayfield Heights, Ohio, United States, 44124

More Information

Sponsor

CatalYm GmbH

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Keywords

  • Cachexia
  • Cancer
  • Weight loss
  • Wasting
  • Anorexia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CatalYm GmbH on 2026-08-31.