{"type":"trials","record":{"id":33568,"source_id":"clinicaltrials-gov","external_id":"NCT05283486","title":"Evaluation of Efficacy, Tolerability, and Pharmacokinetics of MYMD1 for Chronic Inflammation and Sarcopenia/Frailty","brief_summary":"The study will be conducted to investigate the efficacy, tolerability and pharmacokinetics of MYMD1 in participants with chronic inflammation associated with sarcopenia/frailty, a condition linked to elevated levels of proinflammatory cytokines.","overall_status":"Completed","phases":["PHASE2"],"study_type":"INTERVENTIONAL","sponsor":"TNF Pharmaceuticals, Inc.","enrollment":40,"countries":["United States"],"start_date":"2022-02-01","completion_date":"2023-06-07","last_update_date":"2023-10-30","source_url":"https://clinicaltrials.gov/study/NCT05283486","editorial_summary":"A registered PHASE2 study indexed because it matched monitored longevity research terms. Registry status: Completed. Registration does not establish safety or effectiveness.","first_seen_at":"2026-09-25T01:20:11.10691+00:00","last_seen_at":"2026-09-25T06:10:25.747+00:00","metadata":{"sex":"ALL","acronym":null,"age_range":"65 Years to 99 Years","comparator":"Cohort 1: Placebo 600mg; Cohort 2: Placebo 750mg; Cohort 3: Placebo 900mg; Cohort 4: MYMD1 1050mg; Cohort 4: Placebo group 1050mg","organization":"TNF Pharmaceuticals, Inc.","interventions":["MYMD-1 600MG","MYMD-1 750mg","MYMD-1 900mg","MYMD-1 1050mg","placebo 600mg","placebo 750mg","placebo 900mg","placebo 1050mg"],"registry_source":"ClinicalTrials.gov","outcome_measures":["Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Screening","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 1","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 7","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 14","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 21","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 28","To evaluate the PK of oral doses of MYMD1 capsules — Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8,…","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 1 (predose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 1 (0-4 hrs post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 1 (4-8 hrs post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 1(8-24hrs post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 7 (predose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 7 (0-4 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 7 (4-8 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 7 (8-24hrs post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 14 (predose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 14 (0-4 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 14 (4-8 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 14 (8-24 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 21 (predose)"],"design_description":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","source_has_results":false},"controlled_terms":["Sarcopenia","Frailty","Aging","MYMD-1 600MG","MYMD-1 750mg","MYMD-1 900mg","MYMD-1 1050mg","placebo 600mg","placebo 750mg","placebo 900mg","placebo 1050mg"],"relevance_confidence":100,"source_quality_score":100,"freshness_score":65,"publication_state":"published","match_explanation":"Title contains controlled term: sarcopenia.","quality_checked_at":"2026-09-25T06:10:37.875473+00:00","duplicate_cluster_key":"id:nct05283486","duplicate_of_id":null,"evidence_snapshot":{"status":"structured","version":1,"duration":"2022-02-01 to 2023-06-07","comparator":"Cohort 1: Placebo 600mg; Cohort 2: Placebo 750mg; Cohort 3: Placebo 900mg; Cohort 4: MYMD1 1050mg; Cohort 4: Placebo group 1050mg","confidence":"structured-source","population":"ALL · 65 Years to 99 Years","provenance":{"duration":"start_date and completion_date","comparator":"registry arm fields","population":"registry eligibility fields","intervention":"registry intervention fields","participants":"enrollment","study_design":"study_type and registry design fields","evidence_stage":"phases","reported_outcome":"not available","outcomes_measured":"registry outcome-measure fields"},"generated_at":"2026-09-25T06:10:25.856Z","intervention":["MYMD-1 600MG","MYMD-1 750mg","MYMD-1 900mg","MYMD-1 1050mg","placebo 600mg","placebo 750mg","placebo 900mg","placebo 1050mg"],"participants":40,"study_design":"RANDOMIZED · PARALLEL · TREATMENT · QUADRUPLE","subject_scope":"Human clinical study registration","evidence_stage":"PHASE2","safety_context":"Eligibility, adverse-event details, and clinical decisions must be checked in the official registry and with qualified clinicians.","source_support":"Structured registry protocol metadata; no finding-level conclusion is generated.","main_limitation":"This is a study registration. No reusable structured result is available here, so it cannot show whether the intervention worked or was safe.","reported_outcome":null,"outcomes_measured":["Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Screening","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 1","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 7","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 14","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 21","Demonstrate reduction of chronic inflammatory markers in participants treated with MYMD1 — Day 28","To evaluate the PK of oral doses of MYMD1 capsules — Cohorts 1, 2, 3, 4: pre-dose, 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 8,…","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 1 (predose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 1 (0-4 hrs post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 1 (4-8 hrs post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 1(8-24hrs post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 7 (predose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 7 (0-4 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 7 (4-8 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 7 (8-24hrs post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 14 (predose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 14 (0-4 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 14 (4-8 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 14 (8-24 hours post dose)","To evaluate the PK (urine) of oral doses of MYMD1 capsules — Day 21 (predose)"],"regulatory_context":"Trial registration is not regulatory approval and does not establish that an intervention is available."},"clinical_trial_topics":[{"topic_slug":"chronic-inflammation","is_published":true,"match_reasons":["Title contains controlled term: chronic inflammation.","Abstract contains controlled term: chronic inflammation.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Chronic inflammation","slug":"chronic-inflammation"}},{"topic_slug":"sarcopenia","is_published":true,"match_reasons":["Title contains controlled term: sarcopenia.","Abstract contains controlled term: sarcopenia.","Source terminology contains: sarcopenia.","Title supplies longevity context: frailty, frail.","Study type is explicitly identified as INTERVENTIONAL."],"matched_fields":["title","abstract","controlled terminology","title context","study type"],"relevance_score":100,"intelligence_topics":{"name":"Sarcopenia","slug":"sarcopenia"}}],"content_sources":{"name":"ClinicalTrials.gov","homepage_url":"https://clinicaltrials.gov/"}},"canonical_url":"https://www.immortal.life/trials/33568","automation_disclosure":"Generated automatically from cited source metadata. No scientist, clinician, researcher, editor, or human reviewer evaluates this publication before release."}