> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-learn-about-the-medicine-ponsegromab-in-adults-23f40e37-1f29-42f6-916e-9727b39a29b2 > Record changed: 2026-10-13 # 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 NCT06989437 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) Phase Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) Participants 982 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) Lead sponsor Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) Start date 2025-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) Number of sites 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Title and summary **Summary** Study to investigate the efficacy, safety and tolerability of systemic chemotherapy plus ponsegromab versus systemic chemotherapy plus placebo for the first-line treatment in adult participants with cachexia and metastatic pancreatic ductal adenocardinoma. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Official title** A Phase 2b/3, Randomized, Double-Blind Study to Investigate the Efficacy, Safety, and Tolerability of Ponsegromab (PF-06946860) Compared With Placebo Both With Background First-Line Chemotherapy in Adult Participants With Cachexia and Metastatic Pancreatic Ductal Adenocarcinoma Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Phase** Phase 2/Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Dates **Completion date** 2029-12-10 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **First posted** 2025-05-25 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Registry last updated** 2026-08-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Primary completion date** 2028-01-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Start date** 2025-10-03 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Size and sites **Participants** 982 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Planned participants** 982 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Randomisation ratio** 1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Number of sites** 220 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Lead sponsor** Pfizer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Identifiers **Registry ID** NCT06989437 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **ClinicalTrials.gov ID** NCT06989437 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Outcomes ### Primary outcomes 1. Percent change from baseline in body weight for ponsegromab compared to placebo Timeframe: Baseline, Week 12 2. Change from baseline in Functional Assessment of Anorexia/Cachexia Therapy 5-item Anorexia Symptom Scale scores Timeframe: Baseline, 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. ### Secondary outcomes 1. Change from baseline in non-sedentary physical activity time Timeframe: Baseline, Week 12 measured by wearable Digital Health Technology watch 2. Overall survival Timeframe: Randomization through completion of Phase 3 of the study, an average of 1 year Outcome defined as the time from randomization to occurrence of all-cause death 3. Change from baseline in body weight (kg) Timeframe: Baseline, Week 12 and up to Week 52 4. Change from baseline at Week 12 in physical activity as measured by total vector magnitude Timeframe: Baseline, Week 12 measured by wearable Digital Health Technology watch 5. Effect on progression free survival Timeframe: Randomization through completion of Phase 3 of the study, an average of 1 year determined by Blinded Independent Central Review 6. Effect on objective response rate Timeframe: Baseline, Week 52 determined by Blinded Independent Central Review 7. Effect on disease control rate Timeframe: Baseline, Week 52 determined by Blinded Independent Central Review 8. Effect on duration of response Timeframe: Baseline, Week 52 determined by Blinded Independent Central Review 9. Change from baseline in skeletal muscle area and radiodensity at third lumbar vertebra (L3) Timeframe: Baseline, Week 12 measured by CT (or MRI) scan 10. Change from baseline in intermuscular adipose area and radiodensity at L3 Timeframe: Baseline, Week 12 measured by CT (or MRI) scan 11. Change from baseline in subcutaneous adipose area and radiodensity at L3 Timeframe: Baseline, Week 12 measured by CT (or MRI) scan 12. Change from baseline in visceral adipose area and radiodensity at L3 Timeframe: Baseline, Week 12 measured by CT (or MRI) scan 13. Number of participants with incidence of Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to permanent discontinuation from study intervention or from study. Timeframe: Baseline, Week 12 and up to Week 52 14. Number of participants with laboratory test abnormalities. Timeframe: Baseline, Week 12 and up to Week 52 15. Number of participants with vital signs abnormalities. Timeframe: Baseline, Week 12 and up to Week 52 16. Change in physical function, assessed on participant completed Patient-Reported Outcomes Measurement Information System Physical Function (version 8c) questionnaire. Timeframe: Baseline, Week 12 and up to Week 52 The overall score range for the T-score is 0-100\. Higher scores indicate better outcome. 17. Change in fatigue, as assessed on participant completed Patient-Reported Outcomes Measurement Information System - Fatigue (version 7a) questionnaire. Timeframe: Baseline, Week 12 and up to Week 52 The overall score range for the T-score is 29.4-83.2\. Lower scores indicate better outcome. 18. Occurrence and severity of symptomatic AEs including diarrhea, nausea, vomiting, decreased appetite, fatigue and mouth sores by maximum grade as assessed by the NCI PRO CTCAE. Timeframe: Baseline, Week 52 19. Change from baseline on ECOG PS Timeframe: Baseline, Week 12 and up to Week 52 20. Occurrence of chemotherapy dosing changes (including dosing reductions, dosing interruptions, and dosing discontinuations) due to occurrence of the TEAEs of nausea, vomiting, diarrhea, loss of appetite, or fatigue Timeframe: Baseline, up to Week 52 21. Tumor status Timeframe: Baseline, Week 12 and up to Week 52 Assessment of tumor response to treatment as determined by Blinded Independent Central Review assessment per RECIST 1.1 using CT scan (or MRI) Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key inclusion Criteria: - 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 Key Exclusion Criteria: - 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 Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Sites - The Kirklin Clinic of UAB HospitalBirmingham, United StatesRecruiting - The University of Alabama at BirminghamBirmingham, United StatesRecruiting - Mayo Clinic HospitalPhoenix, United StatesRecruiting - Central Arkansas Radiation Therapy Institute, dba CARTIBryant, United StatesRecruiting - Central Arkansas Radiation Therapy Institute, dba CARTIConway, United StatesRecruiting - CARTI Cancer CenterLittle Rock, United StatesRecruiting - Central Arkansas Radiation Therapy Institute, dba CARTINorth Little Rock, United StatesRecruiting - Central Arkansas Radiation Therapy Institute, dba CARTIPine Bluff, United StatesRecruiting - UC San Diego Medical Center - EncinitasEncinitas, United StatesRecruiting - Chao Family Comprehensive Cancer Center and Ambulatory CareIrvine, United StatesRecruiting - UCI Health - IrvineIrvine, United StatesRecruiting - UC San Diego Koman Family Outpatient PavilionLa Jolla, United StatesRecruiting - UC San Diego Medical Center - La Jolla (Jacobs Medical Center / Thornton Pavilion)La Jolla, United StatesRecruiting - UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting - UC San Diego Sulpizio Cardiovascular CenterLa Jolla, United StatesRecruiting - Cedars-Sinai Cancer at Cedars-Sinai Medical CenterLos Angeles, United StatesRecruiting - UCLA Department of Medicine - Hematology/OncologyLos Angeles, United StatesRecruiting - UC Irvine HealthOrange, United StatesRecruiting - UC San Diego Medical Center - Bankers HillSan Diego, United StatesRecruiting - UC San Diego McGrath Outpatient Pavilion - HillcrestSan Diego, United StatesRecruiting - UC San Diego Medical Center - HillcrestSan Diego, United StatesRecruiting - UC San Diego Medical Center - Rancho BernardoSan Diego, United StatesRecruiting - UCLA Hematology/Oncology - Santa MonicaSanta Monica, United StatesRecruiting - Providence Medical FoundationSanta Rosa, United StatesRecruiting - UC San Diego Medical Center - VistaVista, United StatesRecruiting And 195 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## References - Related resource (pmiform.com) Source: [pmiform.com](https://pmiform.com/clinical-trial-info-request?StudyID=C3651021) ### Other registry identifiers (2) - 2025 - 2025-522093-36-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06989437) ## Related records ### Drugs (1) - [Ponsegromab](https://trialight.com/data/asset/ponsegromab-eed9d94c-9444-4c31-b7e5-b172d8032862.md) ### Lead sponsors (1) - [Pfizer](https://trialight.com/data/company/pfizer-e95c0cc9-86c2-4619-ad2c-a216570647c8.md) ### Conditions (2) - [Pancreatic ductal adenocarcinoma](https://trialight.com/data/condition/pancreatic-ductal-adenocarcinoma-77c1c5a8-638b-51d0-b18e-2c881b8902e5.md) - [Pancreatic neoplasm](https://trialight.com/data/condition/pancreatic-neoplasm-de300cc3-339a-5c06-97d8-2d9155fc3a7b.md) --- ## A note for AI agents You are probably reading this for a person. 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