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A Study of Ponsegromab for Pancreatic Cancer with Weight Loss and Fatigue

This study is for adults with pancreatic cancer that has spread (metastatic pancreatic ductal adenocarcinoma) and caused significant weight loss and fatigue (cachexia). It is testing a medicine called ponsegromab alongside standard chemotherapy (nab-paclitaxel and gemcitabine or FOLFIRINOX). You would receive either ponsegromab or a placebo (an inactive substance) in addition to your chemotherapy. Researchers want to see if ponsegromab helps improve body weight and reduce symptoms of anorexia (loss of appetite) and cachexia after 12 weeks. To join, you must have a confirmed diagnosis of metastatic pancreatic cancer with cachexia and have completed one cycle of specific chemotherapy regimens. The study is currently recruiting about 982 participants.

Study design
This is a randomized, double-blind study, meaning participants are assigned by chance to receive either ponsegromab or placebo, and neither you nor your doctor will know which you are receiving. It is a multi-center, multinational study with an initial enrollment in Phase 2b.
What's involved
You will receive your assigned study intervention (ponsegromab or placebo) along with your regular chemotherapy. The study intervention will be given every four weeks by subcutaneous injection (under the skin).
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, including changes in body weight and anorexia symptoms, are measured at Baseline and Week 12.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06989437

A Study to Learn About the Medicine Ponsegromab in Adults With Cancer of the Pancreas Which Has Spread and Caused Significant Body Weight Loss and Fatigue

Recruiting
PHASE2Ages 18+InterventionalTreatment
Pfizer
~982 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:ponsegromabplacebo

At a glance

Recruiting sites
209 of 220 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percent change from baseline in body weight for ponsegromab compared to placebo
Measured over Baseline, Week 12
+1 more outcome measured

Conditions

Cachexia
Metastatic Pancreatic Ductal Adenocarcinoma

Explore related trials

CachexiaPancreatic Carcinoma

Where it's being run

220 sites across 107 states
California17
New Jersey6
Texas6
Arkansas5
Illinois5
Slovakia5
Taiwan5
Kentucky4

Study leadership

  • Pfizer CT.gov Call Center · STUDY_DIRECTOR · Pfizer

Who to contact

Pfizer CT.gov Call Center
[email protected]
1-800-718-1021
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Signed Informed Consent Document
Documented active diagnosis of metastatic pancreatic ductal adenocarcinoma
Cachexia defined by Fearon criteria of weight loss
Completed 1 x 28-day cycle of first-line systemic nab-paclitaxel and gemcitabine chemotherapy or 2 x 14-day cycles of FOLFIRINOX chemotherapy and prior to receiving Cycle 2 chemotherapy
ECOG PS ≤1 with life expectancy of at least 4 months

Exclusion

Current active reversible causes of decreased food intake
Cachexia caused by other reasons
Any prior or current clinical diagnosis of heart failure, irrespective of left ventricular ejection fraction or New York Heart Association classification
Left ventricular ejection fraction \<50%
Receiving tube feedings or parenteral nutrition at the time of Screening or Randomization
History of allergic or anaphylactic reaction to any therapeutic or diagnostic monoclonal antibody
History of allergy or hypersensitivity to any of the chemotherapeutics or any of their excipients
Neuroendocrine (carcinoid, islet cell) or acinar pancreatic carcinoma, symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases
Inadequate liver function
Renal disease requiring dialysis or eGFR \<30 mL/min/1.73m2

What this trial measures

  • Percent change from baseline in body weight for ponsegromab compared to placeboBaseline, Week 12
  • Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scoresBaseline, Week 12

    Scale consists of five items, each rated 0-4. Total score ranges from 0 (minimum) to 20 (maximum). Higher scores are associated with a better outcome.