Actively Recruiting
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Led by Anagram Therapeutics, Inc. · Updated on 2026-05-08
113
Participants Needed
26
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 2 Study to Assess the Safety and Efficacy of ANG003
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 12 years or older in the US and 18 years or older in the EU
- Confirmed and documented diagnosis of cystic fibrosis
- Diagnosed with severe exocrine pancreatic insufficiency defined by fecal elastase ≤50 µg/g stool at screening
- Controlled exocrine pancreatic insufficiency and stable dose of pancreatic enzyme replacement therapy for 90 days prior to screening
- Adequate nutritional status measured by BMI: ≥25th percentile for children aged 12-17 years or ≥18.5 kg/m2 for adults 18 years and older
You will not qualify if you...
- 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 (except resections not causing short bowel syndrome)
- Known severe allergic reaction to any ingredient of the study drug ANG003, Creon, or the stool marker FD&C Blue #2
- Any chronic diarrheal illness unrelated to pancreatic insufficiency
- Currently treated for small intestinal bacterial overgrowth
- Use of naso-gastric, J-tube, G-tube, or enteral feeding during the study
- Clostridioides difficile infection within 6 months prior to screening
- Severe constipation defined as fewer than 1 bowel movement per week
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 26 locations
1
Long Beach Memorial Medical Center
Long Beach, California, United States, 90806
Not Yet Recruiting
2
Center for Cystic Fibrosis at Keck Medical Center of USC
Los Angeles, California, United States, 90033
Not Yet Recruiting
3
National Jewish Health
Denver, Colorado, United States, 80206
Not Yet Recruiting
4
University of Florida
Gainesville, Florida, United States, 32610
Not Yet Recruiting
5
Central Florida Pulmonary Group
Orlando, Florida, United States, 32803
Not Yet Recruiting
6
The Cystic Fibrosis Institute
Glenview, Illinois, United States, 60025
Actively Recruiting
7
University of Iowa
Iowa City, Iowa, United States, 52242
Not Yet Recruiting
8
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
9
University of Kentucky
Lexington, Kentucky, United States, 40506
Not Yet Recruiting
10
MaineHealth Pediatric Specialty Care
Portland, Maine, United States, 04102
Not Yet Recruiting
11
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Not Yet Recruiting
12
Boston Children's Hospita
Boston, Massachusetts, United States, 02115
Not Yet Recruiting
13
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
14
Wayne State University Harper University Hospital
Detroit, Michigan, United States, 48201
Not Yet Recruiting
15
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Not Yet Recruiting
16
New York Medical College at Westchester Medical Center
Valhalla, New York, United States, 10595
Not Yet Recruiting
17
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Not Yet Recruiting
18
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
19
Nationwide Children's Hospital, Columbus
Columbus, Ohio, United States, 43205
Not Yet Recruiting
20
Toledo Children's Hospital
Toledo, Ohio, United States, 43606
Not Yet Recruiting
21
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, United States, 17033
Not Yet Recruiting
22
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15224
Not Yet Recruiting
23
University of Texas Southwestern / Children's Health
Dallas, Texas, United States, 75207
Not Yet Recruiting
24
Adult Cystic Fibrosis Center at the University of Utah
Salt Lake City, Utah, United States, 84112
Not Yet Recruiting
25
University of Wisconsin
Madison, Wisconsin, United States, 53792
Not Yet Recruiting
26
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Not Yet Recruiting
Research Team
E
Evan Bailey, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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