Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15

A PHASE 2, RANDOMIZED, 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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220581

Enrollment

168

Registered

2023-01-22

Start date

2023-01-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer cachexia

Interventions

Drug: ponsegromab Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment Drug: Placebo Double-Blind placebo Treatment followed by Open Label ponsegromab Treatment

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Key Inclusion Criteria: * Documented diagnosis of non-small cell lung, pancreatic, colorectal cancer * Cachexia defined by Fearon criteria * Serum GDF-15 concentrations * Signed informed consent

Exclusion criteria

Exclusion criteria: Key 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

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures : 1.Change from baseline in body weight for ponsegromab compared to placebo [ Time Frame: baseline, Week 12 ]	—

Secondary

Measure	Time frame
Secondary Outcome Measures : 1.Change from baseline in physical activity as measured with remote digital sensors [ Time Frame: baseline, Week 12 ] evaluation of physical activity (Sedentary, light and moderate) and gait speed. 2.change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS and FAACT-5IASS) scores [ Time Frame: baseline, Week 12 ] FACT-G score sums 27 items; ACS score sums 12 items; both use a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life. 3.Incidence of adverse events [ Time Frame: Week 12 ] 4.Incidence of lab abnormalities [ Time Frame: Week 12 ] 5.Incidence of vital sign abnormalities [ Time Frame: Week 12 ] 6.Incidence of ECG abnormalities [ Time Frame: Week 12 ]	—

Measure

Time frame

Secondary Outcome Measures : 1.Change from baseline in physical activity as measured with remote digital sensors [ Time Frame: baseline, Week 12 ] evaluation of physical activity (Sedentary, light and moderate) and gait speed. 2.change from baseline in Functional Assessment of Anorexia-Cachexia Therapy (FAACT-ACS and FAACT-5IASS) scores [ Time Frame: baseline, Week 12 ] FACT-G score sums 27 items; ACS score sums 12 items; both use a 5-point scale (0-4).Higher scores are associated with a higher health-related quality of life. 3.Incidence of adverse events [ Time Frame: Week 12 ] 4.Incidence of lab abnormalities [ Time Frame: Week 12 ] 5.Incidence of vital sign abnormalities [ Time Frame: Week 12 ] 6.Incidence of ECG abnormalities [ Time Frame: Week 12 ]

—

Countries

Australia, Bulgaria, Canada, China, Hungary, Japan, Poland, Slovakia, Spain, Taiwan, United States

Contacts

Public ContactClinical Trials Information Desk

Pfizer R&D Japan G.K.

clinical-trials@pfizer.com+81-3-5309-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026