NCT06052293CompletedPhase 1
Phase 1 Study to Assess Safety and Efficacy of ANG003
A Phase 1 Open-Label, Multicenter Study to Assess the Safety and Efficacy of ANG003 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Source: ClinicalTrials.gov · Last updated 27 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 57 (actual)
- First submitted
- 9 Aug 2023
- Start date
- 25 Aug 2023
- Primary completion date
- 8 Jul 2024
- Lead sponsor
- Anagram Therapeutics, Inc.
- Diseases
- Cystic fibrosis
- NCT number
- NCT06052293
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 57
- From 25 Aug 2023 to the primary completion date, 8 Jul 2024
- 20 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2).
Other illness
- 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.
Other
- 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.
- Subjects who cannot discontinue omega-3 supplements \>500 mg of DHA and EPA daily.
- Subjects unable to tolerate missing a dose of PERT.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (20)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akron Childrens Hospital Coordinator of this site? Confirm its status | Akron | United States | Unknown status |
| Albany Medical College Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| University of Michigan Medical Center Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| University of Cincinnati Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| University Hospitals of Cleveland Medical Center Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Unknown status |
| University of Texas Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| National Jewish Health Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Harper University Hospital / Wayne State University Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Dartmouth Hitchcock Medical Center Coordinator of this site? Confirm its status | Lebanon | United States | Unknown status |
| University of Arkansas for Medical Sciences Coordinator of this site? Confirm its status | Little Rock | United States | Unknown status |
| Long Beach Memorial Medical Center Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine Coordinator of this site? Confirm its status | Louisville | United States | Unknown status |
| Medical College of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| University of Minnesota Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
| UPMC Children's Hospital of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| New York Medical College at Westchester Medical Center Coordinator of this site? Confirm its status | Valhalla | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.