Phase 2 Study to Assess the Safety and Efficacy of ANG003

May 5, 2026 updated by: Anagram Therapeutics, Inc.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

113

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
        • Not yet recruiting
        • Long Beach Memorial Medical Center
        • Contact:
      • Los Angeles, California, United States, 90033
        • Not yet recruiting
        • Center for Cystic Fibrosis at Keck Medical Center of USC
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80206
        • Not yet recruiting
        • National Jewish Health
        • Contact:
    • Florida
      • Gainesville, Florida, United States, 32610
        • Not yet recruiting
        • University of Florida
        • Contact:
      • Orlando, Florida, United States, 32803
    • Illinois
      • Glenview, Illinois, United States, 60025
        • Recruiting
        • The Cystic Fibrosis Institute
        • Contact:
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Not yet recruiting
        • University of Iowa
        • Contact:
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Not yet recruiting
        • University of Kansas Medical Center
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • Not yet recruiting
        • University Of Kentucky
        • Contact:
    • Maine
      • Portland, Maine, United States, 04102
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Not yet recruiting
        • Massachusetts General Hospital
        • Contact:
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Not yet recruiting
        • University of Michigan, Michigan Medicine
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Not yet recruiting
        • Wayne State University Harper University Hospital
        • Contact:
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • Not yet recruiting
        • Rutgers - Robert Wood Johnson Medical School
        • Contact:
    • New York
      • Valhalla, New York, United States, 10595
        • Not yet recruiting
        • New York Medical College at Westchester Medical Center
        • Contact:
    • Ohio
      • Akron, Ohio, United States, 44308
        • Not yet recruiting
        • Children's Hospital Medical Center of Akron
        • Contact:
      • Cleveland, Ohio, United States, 44106
        • Not yet recruiting
        • Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
        • Contact:
      • Columbus, Ohio, United States, 43205
      • Toledo, Ohio, United States, 43606
        • Not yet recruiting
        • Toledo Children's Hospital
        • Contact:
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Not yet recruiting
        • Hershey Medical Center Pennsylvania State University
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15224
        • Not yet recruiting
        • University of Pittsburgh Medical Center
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75207
        • Not yet recruiting
        • University of Texas Southwestern / Children's Health
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Not yet recruiting
        • Adult Cystic Fibrosis Center at the University of Utah
        • Contact:
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
      • Milwaukee, Wisconsin, United States, 53226
        • Not yet recruiting
        • Froedtert & Medical College of Wisconsin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANG003 Dose A
All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is >/= 80%, the subject may be randomized to ANG003 Dose A for a 21-day acclimation and subsequent CFA analysis.
Drug: ANG003 Dose A
160,000 u* lipase, 105,000 u* protease, and 11,600 u* amylase per dose (*units are comparable to United States Pharmacopeiea [USP])
Experimental: ANG003 Dose B
All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is >/= 80%, the subject may be randomized to ANG003 Dose B for a 21-day acclimation and subsequent CFA analysis.
Drug: ANG003 Dose B
240,000 u* lipase, 105,000 u* protease, and 11,600 u* amylase per dose (*units are comparable to United States Pharmacopeiea [USP])
Active Comparator: Creon
All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is >/= 80%, the subject may be randomized to Creon for an additional 21-days and subsequent CFA analysis.
Drug: Creon
The commercially available pPERT Creon will be the active comparator in the study. Subjects will be instructed to take Creon according to the package insert and PI direction.
No Intervention: Off Enzyme
All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. If baseline CFA is >/= 80%, the subject may be randomized to the off enzyme arm. Subjects will receive Creon for an additional 21-day and the subsequent CFA analysis will be off enzyme. Total time off enzyme will be 4-7 days.
Other: 60% to <80% CFA ANG003 Dose B
All subjects will be acclimated to Creon for 14-days and then will undergo a baseline CFA analysis. Participants with a Period A CFA result of 60% to <80% will be assigned to ANG003 Dose B.
Drug: ANG003 Dose B
240,000 u* lipase, 105,000 u* protease, and 11,600 u* amylase per dose (*units are comparable to United States Pharmacopeiea [USP])

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values
Time Frame: From Visit 1 to Visit 5, anticipated average 80 days
Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values
From Visit 1 to Visit 5, anticipated average 80 days
Coefficient of Fat Absorption (CFA)
Time Frame: Period A (baseline) and Period B 72 hour CFA collection
Mean change from baseline CFA (i.e., Period B CFA minus Period A CFA) assessed for ANG003 Dose A, ANG003 Dose B, and Creon amongst subjects with baseline CFA ≥80%.
Period A (baseline) and Period B 72 hour CFA collection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) (ug/mL)
Time Frame: Period A (baseline) and Period B time 0, 1, 2, 4, 6, 8, 10 and 24 hour collections
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Period A (baseline) and Period B time 0, 1, 2, 4, 6, 8, 10 and 24 hour collections
Coefficient of Nitrogen Absorption (CNA)
Time Frame: Period A (baseline) and Period B 72 hour CNA collection
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Period A (baseline) and Period B 72 hour CNA collection
% of subjects with GI symptoms
Time Frame: From Visit 2 to Visit 5, anticipated average 59 days
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
From Visit 2 to Visit 5, anticipated average 59 days
Cumulative stool weight
Time Frame: Period A (baseline) and Period B 72 hour collection
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Period A (baseline) and Period B 72 hour collection
Number of Stools per Day
Time Frame: Period A (baseline) and Period B 72 hour collection
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Period A (baseline) and Period B 72 hour collection

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between DHA/EPA and CFA
Time Frame: Period A (baseline) Period B 72 hour CFA and 24 hour DHA/EPA collection
Mean change from baseline for each treatment group with a baseline CFA ≥80%
Period A (baseline) Period B 72 hour CFA and 24 hour DHA/EPA collection
Coefficient of Fat Absorption (CFA) for subjects with a baseline CFA of 60% to <80% (analyzed separately)
Time Frame: Period A (baseline) and Period B 72 hour CFA collection
Mean change from baseline for each treatment group with a baseline CFA 60% to <80%
Period A (baseline) and Period B 72 hour CFA collection
Mean Period B CFA for all subjects randomized to the Off Enzyme arm with a baseline CFA ≥80%
Time Frame: Period B 72 hour CFA collection
Period B CFA Off Enzyme in subjects with a baseline CFA ≥80%
Period B 72 hour CFA collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anagram Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 26, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANG003-25-201
  • 2025-524569-25-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cystic Fibrosis (CF)

Clinical Trials on ANG003 Dose A

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe