Visugromab in Cachexia International Trial

Conditions

• Cancer-associated Cachexia

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Visugromab (CTL-002) — DRUG
  High dose
• Placebo — DRUG
  IV infusion
• Visugromab (CTL-002) — DRUG
  Medium dose
• Visugromab (CTL-002) — DRUG
  Low dose

Study Details

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.

Key Dates

Start date

Apr 16, 2026

Status verified

Jun 2026

Primary completion

Dec 31, 2029

Completion

Dec 31, 2030

Study Design

Enrollment

518 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Visugromab low dose
• Active Comparator: Visugromab medium dose
• Active Comparator: Visugromab high dose
• Placebo Comparator: Placebo

Primary Outcome Measure

Change from baseline in body weight at 12 weeks [ Time Frame: 12 weeks ]

Central Contacts

• Trial Director
  49 8920006640
  [email protected]

Locations (6)

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