NCT07869147 · Oorja Bio, Inc.
Study of ORJ-001 for the Treatment of IPF
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
ORJ-001
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.
OTHER
Placebo
Matching placebo administered by subcutaneous injection twice weekly.
Primary outcome measures
Part A: Safety and Tolerability of ORJ-001: Number of Participants with Treatment-Related Adverse Events (TEAEs)
Time frame: From first dose through Safety Follow-up Visit, up to 12 weeks.
Number of participants experiencing at least one treatment-emergent adverse event.
Part A: Safety and Tolerability of ORJ-001: Severity of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose through Safety Follow-up Visit, up to 12 weeks.
Severity of treatment-emergent adverse events as graded according to CTCAE v6.0.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Systolic Blood Pressure
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in systolic blood pressure measured in millimeters of mercury (mmHg).
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Body Temperature
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in body temperature measured in degrees Celsius (°C).
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Heart Rate
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in heart rate measured in beats per minute (bpm).
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Respiratory Rate
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in respiratory rate measured in breaths per minute.
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Oxygen Saturation
Time frame: Baseline and each study visit through Safety Follow-up Visit, up to 12 weeks.
Change from baseline in oxygen saturation measured as percentage (% SpO₂).
Part A: Safety and Tolerability of ORJ-001: Change from Baseline in Corrected QT Interval
Time frame: Baseline, Week 4, Week 12, and Safety Follow-up Visit up to 12 weeks.
Change from baseline in corrected QT interval (QTc) measured by electrocardiogram (ECG) in milliseconds (ms).
Part B: Change from Baseline in Forced Vital Capacity (FVC)
Time frame: Baseline to Week 12
Change from baseline in FVC measured by spirometry at Week 12.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male or female participants aged ≥ 40 years when signing informed consent
- Non-smoker or ex-smoker who has stopped smoking for \> 6 months prior to signing informed consent
- Diagnosis of IPF, as defined by 2022 international guidelines and confirmed by centrally adjudicated finding of a definite or probable UIP pattern on HRCT of the chest. The HRCT may be performed at screening or, if available, a historical HRCT obtained within 12 months from screening may be submitted for central review
- FVC of at least 45% of the predicted value and a DLCO, corrected for the hemoglobin level, of at least 25% and no greater than 90% of the predicted value. Note: Each test (FVC and DLCO) may be repeated once after a minimum of 24 hours if the initial result is deemed unreliable by the investigator
- If receiving SOC antifibrotic therapy, participants must be on a stable regimen of a single approved therapy for at least 60 days prior to the screening visit. Participants who have discontinued SOC antifibrotic therapy due to tolerability or lack of response may be enrolled after at least 30 days of discontinuing the SOC antifibrotic therapy.
- Negative serum pregnancy test in women of childbearing potential at the screening visit Key
Exclusion criteria
- Participants who are treatment-naïve with respect to SOC antifibrotic therapies
- Women who are pregnant, nursing, or who plan to become pregnant while in the trial
- Major surgery (including joint surgery) within 8 weeks from screening, or planned major surgery within 4 months following randomization
- Presence of one or more significant concurrent medical conditions that may affect the outcome of the study per investigator judgement
- Participants with relevant airway obstruction, defined as pre bronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) ratio \< 0.7 at screening
- Lower respiratory tract infection requiring antibiotics within 4 weeks from screening, or during the screening period (may be rescreened following recovery)
- Acute IPF exacerbation within 3 months from screening, or during the screening period
- Receiving more than 15 mg per day of prednisone during screening
Where
- Doral, Florida
- DuBois, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2026 · Source of record for eligibility and locations