A phase 2, randomised, double-blind, placebo-controlled study to investigate the efficacy, safety and tolerability of ponsegromab in patients with cancer, cachexia, and elevated concentrations of GDF-15, followed by an optional open-label treatment period.

Trial overview


Non-small Cell Lung Cancer, Pancreatic Cancer, Colorectal Cancer, Loss of Appetite, Fatigue, Cachexia

Study details

A 12 week double blind study to evaluate the efficacy, safety and tolerability of ponsegromab compared to placebo in patients with cancer, cachexia, and elevated GDF 15.

During the initial 12-week treatment period (Part A), a total of 3 doses of ponsegromab or placebo will be administered 4 weeks apart subcutaneously. Each dose contains two injections. Part B is an optional open-label treatment period consisting of ponsegromab administered every 4 weeks subcutaneously for up to one year. Part B does not include placebo.

Eligibility criteria

Inclusion Criteria:

  • Documented diagnosis of non-small cell lung, pancreatic, colorectal cancer
  • Cachexia defined by Fearon criteria of weight loss
  • Serum GDF-15 concentrations
  • Signed informed consent
  • ECOG PS ≤3

Exclusion Criteria:

  • Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization.
  • Current active reversible causes of decreased food intake.
  • Cachexia caused by other reasons.
  • History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody.
  • Inadequate renal or liver function.

Further information

Please click here for more information


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