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Visugromab in Cachexia International Trial

NCT ID: NCT07112196

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

518 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-31

Study Completion Date

2030-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer-associated Cachexia

Keywords

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Cachexia Cancer Weight loss Wasting Anorexia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Visugromab low dose

Group Type ACTIVE_COMPARATOR

Visugromab (CTL-002)

Intervention Type DRUG

Low dose

Visugromab medium dose

Group Type ACTIVE_COMPARATOR

Visugromab (CTL-002)

Intervention Type DRUG

Medium dose

Visugromab high dose

Group Type ACTIVE_COMPARATOR

Visugromab (CTL-002)

Intervention Type DRUG

High dose

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

IV infusion

Interventions

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Visugromab (CTL-002)

High dose

Intervention Type DRUG

Placebo

IV infusion

Intervention Type DRUG

Visugromab (CTL-002)

Medium dose

Intervention Type DRUG

Visugromab (CTL-002)

Low dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CatalYm GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Mid Florida Hematology and Oncology Centers

Orange City, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Trial Director

Role: CONTACT

Phone: 49 8920006640

Email: [email protected]

Other Identifiers

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CTL-002-006

Identifier Type: -

Identifier Source: org_study_id