NCT07450547 Phase 2 Study to Assess the Safety and Efficacy of ANG003
| NCT ID | NCT07450547 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Anagram Therapeutics, Inc. |
| Condition | Exocrine Pancreatic Insufficiency (EPI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 113 participants |
| Start Date | 2026-04-24 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 113 participants in total. It began in 2026-04-24 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In this study, ANG003, a pancreatic enzyme replacement therapy (PERT; commonly called "enzymes"), is being investigated as a potential treatment for exocrine pancreatic insufficiency (EPI). People with EPI due to Cystic Fibrosis (CF) may be eligible to participate in this study. The primary objective of this study is to evaluate the safety of ANG003 and see if it works as well compared to Creon, an approved PERT.
Eligibility Criteria
Inclusion Criteria: 1. Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU 2. Confirmed and documented diagnosis of CF 3. Diagnosed with severe EPI as defined by a fecal elastase ≤50 μg/g stool measured at Screening by a central laboratory. 4. Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to Screening. 5. Adequate nutritional status measured by body mass index (BMI) defined by: 1. BMI ≥25th percentile for children aged 12-17 years 2. BMI ≥18.5 kg/m2 for ≥18 years of age Exclusion Criteria: 1. History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening. 2. History of lung or liver transplant, listing for organ transplant or significant bowel resection within the last 6 months. Subjects with a history of resection that does not result in short bowel syndrome are eligible. 3. Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\&C Blue #2). 4. Any chronic diarrheal illness unrelated to pancreatic insufficiency, actively being treated for small intestinal bacterial overgrowth, requiring use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration, Clostridioides difficile infection within 6 months prior to Screening, or severe constipation defined as \<1 bowel movement/week.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07450547 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Exocrine Pancreatic Insufficiency (EPI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07450547 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07450547 currently recruiting?
Yes, NCT07450547 is actively recruiting participants. Contact the research team at medical@anagramtx.com for enrollment information.
Where is the NCT07450547 trial being conducted?
This trial is being conducted at Long Beach, United States, Los Angeles, United States, Denver, United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT07450547 clinical trial?
NCT07450547 is sponsored by Anagram Therapeutics, Inc.. The trial plans to enroll 113 participants.