NCT07450547From ClinicalTrials.govRecruiting

Phase 2 Study to Assess the Safety and Efficacy of ANG003

A Phase 2, Multicenter, Randomized, Active-controlled Study to Assess the Safety and Efficacy of ANG003 at Two Different Dose Levels in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis

Exocrine Pancreatic Insufficiency (EPI)
Cystic Fibrosis (CF)

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: Anagram Therapeutics, Inc.
Enrolment target: 113
Started: 24 April 2026
Main results due: July 2027
Study sites: 27
Registry updated: 28 September 2026

Can you take part?

Aged 12 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

1. Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU
2. Confirmed and documented diagnosis of CF
3. Diagnosed with severe EPI as defined by a fecal elastase ≤50 μg/g stool measured at Screening by a central laboratory.
4. Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to Screening.
5. Adequate nutritional status measured by body mass index (BMI) defined by:

1. BMI ≥25th percentile for children aged 12-17 years
2. BMI ≥18.5 kg/m2 for ≥18 years of age

Exclusion Criteria:

1. History of fibrosing colonopathy or recurring distal intestinal obstructive syndrome within 6 months of Screening.
2. History of lung or liver transplant, listing for organ transplant or significant bowel resection within the last 6 months. Subjects with a history of resection that does not result in short bowel syndrome are eligible.
3. Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\&C Blue #2).
4. Any chronic diarrheal illness unrelated to pancreatic insufficiency, actively being treated for small intestinal bacterial overgrowth, requiring use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration, Clostridioides difficile infection within 6 months prior to Screening, or severe constipation defined as \<1 bowel movement/week.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(27)

Long Beach Memorial Medical Center
Long Beach, California, United States
Recruiting
Center for Cystic Fibrosis at Keck Medical Center of USC
Los Angeles, California, United States
Recruiting
National Jewish Health
Denver, Colorado, United States
Recruiting
University of Florida
Gainesville, Florida, United States
Not yet recruiting
Central Florida Pulmonary Group
Orlando, Florida, United States
Not yet recruiting
The Cystic Fibrosis Institute
Glenview, Illinois, United States
Recruiting
University of Iowa
Iowa City, Iowa, United States
Not yet recruiting
University of Kansas Medical Center
Kansas City, Kansas, United States
Recruiting
University of Kentucky
Lexington, Kentucky, United States
Recruiting
MaineHealth Pediatric Specialty Care
Portland, Maine, United States
Not yet recruiting
Massachusetts General Hospital
Boston, Massachusetts, United States
Not yet recruiting
Boston Children's Hospita
Boston, Massachusetts, United States
Recruiting
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, United States
Recruiting
Wayne State University Harper University Hospital
Detroit, Michigan, United States
Recruiting
University of Minnesota
Minneapolis, Minnesota, United States
Recruiting
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Recruiting
New York Medical College at Westchester Medical Center
Valhalla, New York, United States
Not yet recruiting
Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Recruiting
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Not yet recruiting
Nationwide Children's Hospital, Columbus
Columbus, Ohio, United States
Recruiting
Toledo Children's Hospital
Toledo, Ohio, United States
Recruiting
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, United States
Recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Not yet recruiting
University of Texas Southwestern / Children's Health
Dallas, Texas, United States
Recruiting
Adult Cystic Fibrosis Center at the University of Utah
Salt Lake City, Utah, United States
Recruiting
University of Wisconsin
Madison, Wisconsin, United States
Recruiting
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Not yet recruiting

Showing 27 of 27 sites. 18 of the 27 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07450547. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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