Phase 1
N=57
Phase 1 Study to Assess Safety and Efficacy of ANG003
Exocrine Pancreatic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT06052293 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and AEs Leading to Study Discontinuation — 8; 8; 7; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- ANG003 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Anagram Therapeutics, Inc.
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and AEs Leading to Study Discontinuation |
8; 8; 7; 7; 0; 0 | — |
Summary
Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency. The study's overall objectives are to evaluate the safety, tolerability and effect of four dose levels of ANG003.
Eligibility Criteria
Inclusion Criteria
- Male and female subjects 18 years of age or older.
- Confirmed diagnosis of CF defined as: a) CF signs and symptoms AND b) Two CF-causing mutations on genetic testing or sweat chloride >60 mEq/L.
- Documented history of fecal elastase 5% of body weight within 1 month.
- Requires use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration.
- CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2).
- Subjects who cannot discontinue omega-3 supplements >500 mg of DHA and EPA daily.
- Subjects unable to tolerate missing a dose of PERT.
Data sourced from ClinicalTrials.gov (NCT06052293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.