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ANG003 for pancreatic enzyme replacement in cystic fibrosis–related exocrine pancreatic insufficiency

A Phase 2, Multicenter, Randomized, Active-controlled Study to Assess the Safety and Efficacy of ANG003 at Two Different Dose Levels in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Phase 2 Interventional Anagram Therapeutics, Inc. · NCT07450547

This trial will test whether ANG003, a new pancreatic enzyme replacement, works as well as Creon for people with cystic fibrosis who have exocrine pancreatic insufficiency.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment113 (estimated)
Ages12 Years and up
SexAll
SponsorAnagram Therapeutics, Inc. Industry-sponsored
Locations26 sites (Long Beach, California and 25 other locations)
Trial IDNCT07450547 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study compares two dose levels of ANG003 to an approved pancreatic enzyme replacement, Creon, in people with cystic fibrosis and severe exocrine pancreatic insufficiency. Eligible participants must have confirmed CF, fecal elastase ≤50 μg/g, be on a stable PERT dose for at least 90 days, and meet age and BMI requirements. The primary objective is to evaluate the safety of ANG003 and see if it works as well as Creon. The study is sponsored by Anagram Therapeutics with sites in California and Colorado.

Who should consider this trial

Good fit: Ideal candidates are people with confirmed cystic fibrosis aged ≥12 years in the US (≥18 in the EU) who have severe EPI (fecal elastase ≤50 μg/g), are nutritionally stable, and have been on a stable PERT dose for at least 90 days.

Not a fit: Patients with recent fibrosing colonopathy, recent transplant or listing for transplant, recent significant bowel resection, known hypersensitivity to PERTs, or those who do not meet the age/BMI criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, ANG003 could provide an additional effective PERT option for controlling malabsorption symptoms in people with CF-related EPI.

How similar studies have performed: Approved PERTs such as Creon are already proven to treat EPI, but ANG003 is a new formulation being directly compared to an established product and has limited prior published efficacy data.

Eligibility criteria

Show full inclusion / exclusion 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.

Where this trial is running

Long Beach, California and 25 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Exocrine Pancreatic InsufficiencyCystic FibrosisEPI
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.