A Phase 2 interventional study of ORJ-001 and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by Oorja Bio, Inc.. Recruiting at 2 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Oorja Bio, Inc. · Phase 2, Interventional, and Treatment
ORJ-001 is a new class of drugs intended for the treatment of patients with idiopathic pulmonary fibrosis (IPF). This is a Phase 2 study in two parts; the objective of Part A will determine if ORJ-001 is well-tolerated by patients and how long the drug stays in the body. Part B will test how well the drug affects lung function. Animal models of IPF have shown that ORJ-001 can repair damaged lung tissue and improve markers of lung function.
This Phase 2a/2b, randomized, double-blind, placebo-controlled, multicenter study will evaluate the safety, tolerability, and efficacy of ORJ-001 administered subcutaneously twice weekly in adults with IPF. The study consists of two parts. Part A will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of two dose levels of ORJ-001 compared with placebo over 12 weeks of treatment. Data from Part A will be reviewed by an independent Data Monitoring Committee to select the dose for Part B. Participants in Part A will not continue into Part B; Part B will enroll a separate cohort of participants. Part B will evaluate the efficacy of the selected ORJ-001 dose compared with placebo, with the primary efficacy endpoint being change from baseline in forced vital capacity (FVC) at Week 12. Secondary and exploratory assessments include percent predicted FVC, time to acute IPF exacerbation, respiratory hospitalization or death, patient-reported outcomes, pharmacokinetics, and biomarkers of fibrosis. Adults aged 40 years or older with confirmed IPF and adequate pulmonary function who are receiving stable antifibrotic standard-of-care therapy, or who have previously discontinued such therapy due to tolerability or lack of response, may be eligible to participate.
565 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 117 are open to participants now.
This study's planned enrollment of 95 is above the median of 55 across 388 interventional studies indexed under Idiopathic Pulmonary Fibrosis.
Browse Idiopathic Pulmonary Fibrosis studies →This is the only study on the registry with Oorja Bio, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Participants receive ORJ-001 400 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (400 mg:200 mg:placebo).
Drug: ORJ-001 · Other: Placebo
Participants receive ORJ-001 200 mg administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Randomization ratio: 3:1:1 (active:active:placebo).
Drug: ORJ-001 · Other: Placebo
Participants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks.
Other: Placebo
Participants receive the ORJ-001 dose selected based on Part A safety, tolerability, pharmacokinetic, pharmacodynamic, and efficacy data, administered subcutaneously (SC) twice weekly (BIW) for 12 weeks. Participants are randomized 1:1 to ORJ-001 or placebo.
Drug: ORJ-001 · Other: Placebo
Participants receive matching placebo administered subcutaneously (SC) twice weekly (BIW) for 12 weeks.
Other: Placebo
ORJ-001 is a peptide agonist of β1 integrin administered by subcutaneous injection twice weekly. In Part A, dose levels are 200 mg and 400 mg. In Part B, a single dose level selected from Part A will be evaluated.
Matching placebo administered by subcutaneous injection twice weekly.
Part A: Safety and Tolerability of ORJ-001: Number of Participants with Treatment-Related Adverse Events (TEAEs)
Number of participants experiencing at least one treatment-emergent adverse event.
Time frame: From first dose through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Severity of Treatment-Emergent Adverse Events (TEAEs)
Severity of treatment-emergent adverse events as graded according to CTCAE v6.0.
Time frame: From first dose through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Systolic Blood Pressure
Change from baseline in systolic blood pressure measured in millimeters of mercury (mmHg).
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Body Temperature
Change from baseline in body temperature measured in degrees Celsius (°C).
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Heart Rate
Change from baseline in heart rate measured in beats per minute (bpm).
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Respiratory Rate
Change from baseline in respiratory rate measured in breaths per minute.
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Oxygen Saturation
Change from baseline in oxygen saturation measured as percentage (% SpO₂).
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Corrected QT Interval
Change from baseline in corrected QT interval (QTc) measured by electrocardiogram (ECG) in milliseconds (ms).
Time frame: Baseline, Week 4, Week 12, and Safety Follow-up Visit up to 12 weeks.
Part B: Change from Baseline in Forced Vital Capacity (FVC)
Change from baseline in FVC measured by spirometry at Week 12.
Time frame: Baseline to Week 12
Part B: Change From Baseline in Percent Predicted Forced Vital Capacity (FVC%)
Change from baseline in percentage of predicted FVC measured by spirometry at Week 12.
Time frame: Baseline to Week 12.
Part B: Time to Acute Exacerbation of IPF, Hospitalization for a Respiratory Cause, or Death
Time, in days, to first occurrence of acute IPF exacerbation, hospitalization for a respiratory cause, or death.
Time frame: Up to Week 12.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Jan 2029, 27 months later.
Of 64 industry-sponsored phase 2 interventional studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 48. This study's planned 27 months is close to that.
Counting every sponsor, half of 77 studies reached it within 30 months; a quarter within 21 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Idiopathic Pulmonary Fibrosis →