Phase 1 Study to Assess Safety and Efficacy of ANG003

Completed · Phase 1

Conditions studied: Exocrine Pancreatic Insufficiency

In brief

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.

Key facts

Study ID

NCT06052293

Run by

Anagram Therapeutics, Inc.

People needed

57

Starts

2023-08-25

Expected to finish

2024-07-08

Last updated by the study team

2026-04-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• National Jewish Health — Denver, Colorado, United States
• Norton Children's Research Institute affiliated with University of Louisville School of Medicine — Louisville, Kentucky, United States
• Massachusetts General Hospital, — Boston, Massachusetts, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Michigan Medical Center — Ann Arbor, Michigan, United States
• Harper University Hospital / Wayne State University — Detroit, Michigan, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Albany Medical College — Albany, New York, United States
• New York Medical College at Westchester Medical Center — Valhalla, New York, United States
• Akron Childrens Hospital — Akron, Ohio, United States
• University of Cincinnati — Cincinnati, Ohio, United States
• University Hospitals of Cleveland Medical Center — Cleveland, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• UPMC Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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