CompletedPhase 1

Phase 1 Study to Assess Safety and Efficacy of ANG003

United States57 participantsStarted 2023-08-25

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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 \<100 µg/g stool.
✓. EPI clinically controlled with minimal clinical symptoms and on a stable dose of PERT for 90 days before screening as determined by the Investigator.
✓. Adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects.

Exclusion criteria

✕. Subjects with diabetes mellitus who are unable to refrain from short-acting and rapid-acting insulin on Days 1 and 5 for a daily total of 6 hours.
✕. Involuntary loss of ≥10% of usual body weight within last 6 months or involuntary loss of \>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.

What they're measuring

Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and AEs Leading to Study Discontinuation

Timeframe: Assessed through study completion, up to 9 days (Day 1 thru Day 9).

Trial details

NCT IDNCT06052293

SponsorAnagram Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-07-08

Results submitted2025-07-08

View on ClinicalTrials.gov More Exocrine Pancreatic Insufficiency trials