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RecruitingPhase 2

Phase 2 Study to Assess the Safety and Efficacy of ANG003

Anagram Therapeutics, Inc. · NCT07450547

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 12+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
113
US sites recruiting
20
Study start
April 24, 2026
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: ANG003 Dose A; ANG003 Dose B; Creon

Conditions: Exocrine Pancreatic Insufficiency (EPI); Cystic Fibrosis (CF)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Male and female subjects aged ≥12 years from the date of informed consent in the US and aged ≥18 years in the EU
  • Confirmed and documented diagnosis of CF
  • Diagnosed with severe EPI as defined by a fecal elastase ≤50 μg/g stool measured at Screening by a central laboratory.
  • Subject has controlled EPI and taking a stable dose of pancreatic enzyme replacement therapy (PERT) for 90 days prior to Screening.
  • Adequate nutritional status measured by body mass index (BMI) defined by:
  • BMI ≥25th percentile for children aged 12-17 years
  • BMI ≥18.5 kg/m2 for ≥18 years of age

Exclusion Criteria

  • 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. Subjects with a history of resection that does not result in short bowel syndrome are eligible.
  • Known hypersensitivity or other severe reaction to any ingredient of the investigational product (IP), Creon, or the stool marker (FD\&C Blue #2).
  • 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.

Recruiting US locations

  • Long Beach Memorial Medical Center

    Long Beach, CA 90806

    Site contact: Angelica Rodriguez · 562-706-1245 · ARodriguez9@memorialcare.org

  • Center for Cystic Fibrosis at Keck Medical Center of USC

    Los Angeles, CA 90033

    Site contact: Lynn Fukushima · 323-442-8522 · lynn.fukushima@med.usc.edu

  • National Jewish Health

    Denver, CO 80206

    Site contact: Alix Wilson · 303-270-2517 · wilsona@njhealth.org

  • The Cystic Fibrosis Institute

    Glenview, IL 60025

    Site contact: Steven R Boas, MD · 847-998-3434 · sboas@wecare4lungs.com

  • University of Kansas Medical Center

    Kansas City, KS 66160

    Site contact: Lawrence Scott · 913-588-4020 · lscott2@kumc.edu

  • University of Kentucky

    Lexington, KY 40506

    Site contact: Chase Whitaker · 859-218-4810 · chase.whitaker@uky.edu

  • Massachusetts General Hospital

    Boston, MA 02114

    Site contact: Margot Hardcastle · 617-726-3719 · mhardcastle@mgh.harvard.edu

  • Boston Children's Hospita

    Boston, MA 02115

    Site contact: Robert Fowler · 617-355-1834 · Robert.fowler@childrens.harvard.edu

  • University of Michigan, Michigan Medicine

    Ann Arbor, MI 48109

    Site contact: Dawn Kruse · 734-615-3266 · dmkruse@med.umich.edu

  • Wayne State University Harper University Hospital

    Detroit, MI 48201

    Site contact: Debra Driscoll · 313-745-2221 · ddriscol@med.wayne.edu

  • University of Minnesota

    Minneapolis, MN 55455

    Site contact: Brooke Noren, RN, BSN, CCRC · 612-625-7995 · boer0039@umn.edu

  • Rutgers - Robert Wood Johnson Medical School

    New Brunswick, NJ 08903

    Site contact: Sheila Redding · 732-235-7840 · sr1238@rwjms.rutgers.edu

  • Children's Hospital Medical Center of Akron

    Akron, OH 44308

    Site contact: Michelle Parrish · 330-543-3089 · MParrish@akronchildrens.org

  • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center

    Cleveland, OH 44106

    Site contact: Primary RC & Participant Contact General Contact · 216-844-3911 · RainbowCFResearch@UHhospitals.org

  • Nationwide Children's Hospital, Columbus

    Columbus, OH 43205

    Site contact: Diana Gilmore · 614-722-4752 · diana.gilmore@nationwidechildrens.org

  • Toledo Children's Hospital

    Toledo, OH 43606

    Site contact: Kelly Hoot · 419-291-4630 · kelly.hoot@promedica.org

  • Hershey Medical Center Pennsylvania State University

    Hershey, PA 17033

    Site contact: Diane Kitch · 717-531-5646 · dkitch@pennstatehealth.psu.edu

  • University of Texas Southwestern / Children's Health

    Dallas, TX 75207

    Site contact: Keianna Brown · 214-456-5489 · Keianna.brown@utsouthwestern.edu

  • Adult Cystic Fibrosis Center at the University of Utah

    Salt Lake City, UT 84112

    Site contact: Kristyn Packer · 801-520-5106 · kristyn.packer@hsc.utah.edu

  • University of Wisconsin

    Madison, WI 53792

    Site contact: Melanie Nelson · 608-265-4617 · mnelson@pediatrics.wisc.edu

Study contacts (from the official record)

  • Evan Bailey, MD · 617-466-3111 · medical@anagramtx.com
Phase 2 Study to Assess the Safety and Efficacy of ANG003 (NCT07450547) | Bored Studies