> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/study-to-evaluate-the-efficacy-safety-and-tolerability-of-99fd43c6-7a2d-4285-9f1b-0a46f5b3af93 > Record changed: 2026-10-13 # Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis NCT07284459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) Participants 324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) Lead sponsor Contineum Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) Start date 2026-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) Number of sites 69 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## Title and summary **Summary** This is a Ph 2, randomized, double-blind, placebo-controlled global multicenter study to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of PIPE-791 in participants with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) with or without background treatment. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Short title** Study to Evaluate the Efficacy, Safety, and Tolerability of PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Official title** A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Oral PIPE 791 in Subjects With Idiopathic Pulmonary Fibrosis Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## Dates **Completion date** 2028-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **First posted** 2025-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Registry last updated** 2026-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Primary completion date** 2028-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Start date** 2026-01-08 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## Size and sites **Participants** 324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Planned participants** 324 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Number of sites** 69 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Lead sponsor** Contineum Therapeutics Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## Identifiers **Registry ID** NCT07284459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **ClinicalTrials.gov ID** NCT07284459 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## 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/NCT07284459) ## Outcomes ### Primary outcomes 1. Absolute change in forced vital capacity (FVC) (mL) Timeframe: From baseline to Week 26 ### Secondary outcomes 1. To investigate the safety and tolerability of PIPE-791 compared to placebo based on percentage of treatment-emergent adverse events (TEAE) Timeframe: From baseline to Week 30 2. Relative change in FVC (mL) Timeframe: From baseline to Week 26 Additional assessment of disease progression through lung function measurements 3. Proportion of participants with a ≥10% absolute decline in percent predicted FVC (ppFVC) Timeframe: From baseline to Weeks 12 and Week 26 4. Time to first ≥10% absolute decline in ppFVC Timeframe: From baseline to time of first ≥10% absolute decline, up to Week 26 5. Absolute change in ppFVC Timeframe: From baseline to Week 26 Additional assessment of disease progression through lung function measurements 6. Relative change in ppFVC Timeframe: From baseline to Week 26 Additional assessment of disease progression through lung function measurements 7. Change in quantitative CT-derived lung fibrosis burden on HRCT Timeframe: From baseline to Week 26 Additional assessment of disease progression through imaging Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 40 Years **Healthy volunteers** No Key Inclusion Criteria: - Male or female ≥ 40 years of age at the time of Randomization. - A diagnosis of IPF within 7 years prior to Screening, based on the 2022 ATS/ERS/JRS/ALAT practice guideline as confirmed by the Investigator, and a centrally read screening HRCT consistent with usual interstitial pneumonia (UIP) or probable UIP. - Percent predicted (pp) FVC ≥ 40% on Screening spirometry. - Participants may enter the study whether or not they are receiving background nintedanib or pirfenidone therapy approved for the treatment of IPF, but not both concurrently. Key Exclusion Criteria: - Those with a history of interstitial lung disease (ILD) other than IPF are not eligible. - Those with pulmonary arterial hypertension (PAH) requiring multi-drug therapy are not eligible. - Those who have experienced an IPF exacerbation within 6 weeks of Screening, or during Screening, are not eligible. - Those with an estimated glomerular filtration rate (eGFR) ≤ 30 ml/min/1.73 m2 (Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] formula) (Inker 2021) or who have Child-Pugh Class B or C hepatic impairment are not eligible. - Female participants must not be of childbearing potential. Additional inclusion and exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## Sites - Instituto Ave PulmoMar del Plata, ArgentinaRecruiting - Centro Respiratorio QuilmesQuilmes, ArgentinaRecruiting - Instituto de Especialidades de la Salud Rosario - Clínica del TóraxRosario, ArgentinaRecruiting - Instituto Médico de la Fundación Estudios ClínicosRosario, ArgentinaRecruiting - Centro de Diagnóstico Y Rehabilitación - Santa Fe - San LuisSan Luis, ArgentinaRecruiting - Centro de Investigaciones Médicas Tucumán - PPDSSan Miguel de Tucumán, ArgentinaRecruiting - CIMER-Centro Integral de Medicina RespiratoriaSan Miguel de Tucumán, ArgentinaRecruiting - IPR-Investigaciones en Patologías RespiratoriasSan Miguel de Tucumán, ArgentinaRecruiting - Centro Modelo de Cardiología-Laprida 554San Miguel de Tucumán, ArgentinaRecruiting - STAT Research S.A.Buenos Aires, ArgentinaRecruiting - Consultorios Médicos Organización del Buen Ayre SRLBuenos Aires, ArgentinaRecruiting - Centro Médico Dra de Salvo - Fundacion Respirar - PPDSBuenos Aires, ArgentinaRecruiting - Instituto de Medicina Respiratoria - IMERCórdoba, ArgentinaRecruiting - IbaMedicaSanta Fe, ArgentinaRecruiting - Royal Prince Alfred HospitalCamperdown, AustraliaRecruiting - Westmead HospitalWestmead, AustraliaRecruiting - The Prince Charles HospitalChermside, AustraliaRecruiting - Greenslopes Private HospitalGreenslopes, AustraliaRecruiting - Austin HealthHeidelberg, AustraliaRecruiting - The Alfred HospitalMelbourne, AustraliaRecruiting - Institute for Respiratory HealthMidland, AustraliaRecruiting - TrialsWest Pty LtdSpearwood, AustraliaRecruiting - Vancouver General HospitalVancouver, CanadaRecruiting - Toronto General HospitalToronto, CanadaRecruiting - Dynamic Drug Advancement Ltd.Ajax, CanadaRecruiting And 44 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284459) ## Related records ### Drugs (1) - [Xelafaslatide](https://trialight.com/data/asset/xelafaslatide-acaa45ff-a64e-4124-8a4b-a43b2a5ddf5a.md) ### Lead sponsors (1) - [Contineum Therapeutics](https://trialight.com/data/company/contineum-therapeutics-27d13dc0-8422-4057-b494-13df868037f1.md) ### Conditions (2) - [Idiopathic pulmonary fibrosis](https://trialight.com/data/condition/idiopathic-pulmonary-fibrosis-9d400b0a-ada5-55c8-96c1-87bddcdf6913.md) Primary condition - [Pulmonary fibrosis](https://trialight.com/data/condition/pulmonary-fibrosis-bc07081b-8a87-523b-80ff-c58435a000f3.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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