RecruitingPhase 2

Phase 2 Study to Assess the Safety and Efficacy of ANG003

United States113 participantsStarted 2026-04-24

Plain-language 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.

Who can participate

Age range12 Years

SexALL

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Inclusion criteria

✓. Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU
✓. Confirmed and documented diagnosis of CF
✓. Diagnosed with severe EPI as defined by a fecal elastase ≤50 μg/g stool measured at Screening by a central laboratory.
✓. Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to Screening.
✓. Adequate nutritional status measured by body mass index (BMI) defined by:
✓. BMI ≥25th percentile for children aged 12-17 years
✓. BMI ≥18.5 kg/m2 for ≥18 years of age

Exclusion criteria

✕. History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening.
✕. 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.
✕. Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\&C Blue #2).
✕. 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.

What they're measuring

Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values

Timeframe: From Visit 1 to Visit 5, anticipated average 80 days

Coefficient of Fat Absorption (CFA)

Timeframe: Period A (baseline) and Period B 72 hour CFA collection

Trial details

NCT IDNCT07450547

SponsorAnagram Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-07

Contact for this trial

Evan Bailey, MD

617-466-3111 medical@anagramtx.com

View on ClinicalTrials.gov More Exocrine Pancreatic Insufficiency (EPI) trials