Phase 2 Study to Assess the Safety and Efficacy of ANG003

August 26, 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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
113

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90806
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Center for Cystic Fibrosis at Keck Medical Center of USC
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80206
        • 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
        • Recruiting
        • University of Kansas Medical Center
        • Contact:
    • Kentucky
      • Lexington, Kentucky, United States, 40506
        • 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
        • Recruiting
        • University of Michigan, Michigan Medicine
        • Contact:
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University Harper University Hospital
        • Contact:
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
        • 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
        • 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
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • 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
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 24, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 26, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ANG003-25-201
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 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.

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