{"preliminary_commentary":{"by_channel":{"x_thread":3},"note":"Preliminary. Indexed podcasts, YouTube videos and X posts that name this trial so far. This is where a report starts, not where it ends: the build searches for more, so finished reports usually cover more than this."},"free_build":{"available":false},"commentary_summary":null,"drugs_tested":null,"indication":null,"name":"PROACC-1","nct_id":"NCT05546476","offer":{"currency":"USD","how":"Order at https://www.erudio.com/contact?report=proacc-1-nct05546476. The price is an estimate of verified statements from the commentary indexed so far. Final coverage is set when the report is built. You never pay more than quoted: if the report is delivered at a smaller size, you pay that size's price, and anything paid above it is refunded. We build the report within 24 hours of confirming the order and deliver it when it passes our checks; if it cannot be built to our standard, nothing is charged.","price_rule":"Never more than quoted: the buyer pays the smaller of price_usd and the price the delivered edition is sold at.","price_usd":750,"size":"focused","size_rule":"Focused: 1–150 verified statements, estimated at 14 per indexed commentary source"},"registry":{"acronym":"PROACC-1","arms":[{"description":"ponsegromab low dose subcutaneous injection every 4 weeks","label":"Double-Blind ponsegromab Treatment low dose followed by Open Label ponsegromab Treatment","type":"EXPERIMENTAL"},{"description":"Match placebo subcutaneous injection every 4 weeks","label":"Double-Blind Placebo Treatment followed by Open-Label ponsegromab Treatment","type":"PLACEBO_COMPARATOR"},{"description":"ponsegromab medium dose subcutaneous injection every 4 weeks","label":"Double-Blind ponsegromab Treatment medium dose followed by Open Label ponsegromab Treatment","type":"EXPERIMENTAL"},{"description":"ponsegromab high dose subcutaneous injection every 4 weeks","label":"Double-Blind ponsegromab Treatment high dose followed by Open Label ponsegromab Treatment","type":"EXPERIMENTAL"}],"collaborators":[],"completion_date":{"date":"2025-04-23","type":"ACTUAL"},"conditions":["Non-small Cell Lung Cancer","Pancreatic Cancer","Colorectal Cancer","Loss of Appetite","Fatigue","Cachexia"],"enrollment":{"count":187,"type":"ACTUAL"},"has_results":true,"interventions":[{"name":"ponsegromab","otherNames":[],"type":"DRUG"},{"name":"Placebo for ponsegromab","otherNames":[],"type":"DRUG"}],"last_update":"2026-06-03","lead_sponsor":"Pfizer","official_title":"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 (PROACC -1)","overall_status":"COMPLETED","phases":["PHASE2"],"primary_completion_date":{"date":"2024-03-13","type":"ACTUAL"},"primary_outcomes":[{"measure":"Part A: Change From Baseline in Body Weight at Week 12","timeFrame":"Baseline, Week 12"}],"references":[{"citation":"Groarke JD, Crawford J, Collins SM, Lubaczewski S, Roeland EJ, Naito T, Hendifar AE, Fallon M, Takayama K, Asmis T, Dunne RF, Karahanoglu I, Northcott CA, Harrington MA, Rossulek M, Qiu R, Saxena AR. Ponsegromab for the Treatment of Cancer Cachexia. N Engl J Med. 2024 Dec 19;391(24):2291-2303. doi: 10.1056/NEJMoa2409515. Epub 2024 Sep 14.","pmid":"39282907","type":"DERIVED"},{"citation":"Groarke JD, Crawford J, Collins SM, Lubaczewski SL, Breen DM, Harrington MA, Jacobs I, Qiu R, Revkin J, Rossulek MI, Saxena AR. Phase 2 study of the efficacy and safety of ponsegromab in patients with cancer cachexia: PROACC-1 study design. J Cachexia Sarcopenia Muscle. 2024 Jun;15(3):1054-1061. doi: 10.1002/jcsm.13435. Epub 2024 Mar 18.","pmid":"38500292","type":"DERIVED"}],"start_date":{"date":"2022-11-21","type":"ACTUAL"},"study_type":"INTERVENTIONAL","title":"Study of the Efficacy and Safety of Ponsegromab in Patients With Cancer, Cachexia and Elevated GDF-15","url":"https://clinicaltrials.gov/study/NCT05546476"},"report":null,"schema_id":"erudio.trial_listing","schema_version":"3.2","state":"listed","state_text":"No report yet. It can be ordered.","url":"https://www.erudio.com/trials/proacc-1-nct05546476"}