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RecruitingNCT07112196VINCITUpdated Nov 2, 2026

Visugromab in Cachexia International Trial

A Phase 2/3 interventional study of Visugromab (CTL-002) and Placebo in Cancer-associated Cachexia, sponsored by CatalYm GmbH. Recruiting at 79 sites in 14 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by CatalYm GmbH · Phase 2/3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 6 months later.
Updated Nov 2, 2026First sites in Ireland and Netherlands5 sites addedGo to Updates ↓
Phase
Phase 2/3
Study type
Interventional
Enrollment
518
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Cancer-associated Cachexia

Keywords

  • Cachexia
  • Cancer
  • Weight loss
  • Wasting
  • Anorexia
03

In context

Cachexia

331 studies on the registry are indexed under Cachexia; 75 are open to participants now.

This study's planned enrollment of 518 is above the median of 74 across 226 interventional studies indexed under Cachexia.

Browse Cachexia studies →

Lead sponsor

CatalYm GmbH is the lead sponsor of 6 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Weight loss
  • Advanced cancer

Exclusion criteria

Exclusion Criteria:

  • Participation in another interventional clinical trial, receipt of any therapy or use of any investigational device within 4 weeks prior to screening and between screening and the first dose of investigational product
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
518 participants (estimated)

Study arms

  • Active comparator
    Visugromab low dose

    Drug: Visugromab (CTL-002)

  • Active comparator
    Visugromab medium dose

    Drug: Visugromab (CTL-002)

  • Active comparator
    Visugromab high dose

    Drug: Visugromab (CTL-002)

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

06

What researchers measure

Primary outcomes

  1. Change from baseline in body weight at 12 weeks

    Time frame: 12 weeks

  2. 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)

    Time frame: 12 weeks

07

Study locations

79 of 79 sites recruiting
08

Updates

1 registry update since Sep 25, 2026
Sites
5 sites added — first sites in Ireland and Netherlands
Show 5 added (1 United States, 1 France, 1 Germany, 1 Ireland, 1 Netherlands)
  • Cleveland Clinic Weston Hospital · Weston, United States
  • AP-HP Hopital Cochin · Paris, France
  • Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz · Mainz, Germany
  • St Vincent's University Hospital · Dublin, Ireland
  • Dijklander Ziekenhuis - Locatie Hoorn · Hoorn, Netherlands
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    5 sites added — first sites in Ireland and Netherlands
    Show 5 added (1 United States, 1 France, 1 Germany, 1 Ireland, 1 Netherlands)
    • Cleveland Clinic Weston Hospital · Weston, United States
    • AP-HP Hopital Cochin · Paris, France
    • Universitaetsmedizin der Johannes Gutenberg - Universitaet Mainz · Mainz, Germany
    • St Vincent's University Hospital · Dublin, Ireland
    • Dijklander Ziekenhuis - Locatie Hoorn · Hoorn, Netherlands
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07112196
Lead sponsor
CatalYm GmbH
Responsible party
Sponsor
First posted
Aug 8, 2025
Start date
Apr 16, 2026
Primary completion
Dec 2029 (estimated)
Completion
Dec 2030 (estimated)
Last update
Nov 2, 2026

Study contacts

Trial Director
Contact
regulatory-006@catalym.com
49 8920006640

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Visugromab

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