Exocrine Pancreatic Insufficiency (EPI)Phase 2NCT07450547
Phase 2 Study to Assess the Safety and Efficacy of ANG003
A Phase 2 study testing ANG003 Dose A, ANG003 Dose B and Creon in people with Exocrine Pancreatic Insufficiency (EPI) and Cystic Fibrosis (CF), run by Anagram Therapeutics, Inc. at 27 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
- What is being tested?
- ANG003 Dose A, ANG003 Dose B and Creon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 27 sitesUnited States
- Study dates
- 24 Apr 2026to Jul 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
27 sites in 1 country. Contact the study team or a site near you to ask about taking part.
27 sites in 1 country
United States27 sites, 27 recruiting
- Recruiting
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
Michelle Parrish, 330-543-3089, MParrish@akronchildrens.org
- Recruiting
University of Michigan, Michigan Medicine
Ann Arbor, Michigan, 48109
Dawn Kruse, 734-615-3266, dmkruse@med.umich.edu
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Margot Hardcastle, 617-726-3719, mhardcastle@mgh.harvard.edu
- Recruiting
Boston Children's Hospita
Boston, Massachusetts, 02115
Robert Fowler, 617-355-1834, Robert.fowler@childrens.harvard.edu
- Recruiting
Rainbow Babies and Children's Hospital/University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Primary RC & Participant Contact General Contact, 216-844-3911, RainbowCFResearch@UHhospitals.org
- Recruiting
Nationwide Children's Hospital, Columbus
Columbus, Ohio, 43205
Diana Gilmore, 614-722-4752, diana.gilmore@nationwidechildrens.org
- Recruiting
University of Texas Southwestern / Children's Health
Dallas, Texas, 75207
Keianna Brown, 214-456-5489, Keianna.brown@utsouthwestern.edu
- Recruiting
National Jewish Health
Denver, Colorado, 80206
Alix Wilson, 303-270-2517, wilsona@njhealth.org
- Recruiting
Wayne State University Harper University Hospital
Detroit, Michigan, 48201
Debra Driscoll, 313-745-2221, ddriscol@med.wayne.edu
- Not yet recruiting
University of Florida
Gainesville, Florida, 32610
Alexa Smith, 352-273-8380, alexa.howell@ufl.edu
- Recruiting
The Cystic Fibrosis Institute
Glenview, Illinois, 60025
Steven R Boas, MD, 847-998-3434, sboas@wecare4lungs.com
- Recruiting
Hershey Medical Center Pennsylvania State University
Hershey, Pennsylvania, 17033
Diane Kitch, 717-531-5646, dkitch@pennstatehealth.psu.edu
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
Mary Teresi, 319-384-7546, mary-teresi@uiowa.edu
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
Lawrence Scott, 913-588-4020, lscott2@kumc.edu
- Recruiting
University of Kentucky
Lexington, Kentucky, 40506
Chase Whitaker, 859-218-4810, chase.whitaker@uky.edu
- Recruiting
Long Beach Memorial Medical Center
Long Beach, California, 90806
Angelica Rodriguez, 562-706-1245, ARodriguez9@memorialcare.org
- Recruiting
Center for Cystic Fibrosis at Keck Medical Center of USC
Los Angeles, California, 90033
Lynn Fukushima, 323-442-8522, lynn.fukushima@med.usc.edu
- Recruiting
University of Wisconsin
Madison, Wisconsin, 53792
Melanie Nelson, 608-265-4617, mnelson@pediatrics.wisc.edu
- Not yet recruiting
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Erin Hubertz, 414-955-7019, ehubertz@mcw.edu
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Brooke Noren, RN, BSN, CCRC, 612-625-7995, boer0039@umn.edu
- Recruiting
Rutgers - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903
Sheila Redding, 732-235-7840, sr1238@rwjms.rutgers.edu
- Not yet recruiting
Central Florida Pulmonary Group
Orlando, Florida, 32803
Desiree Serr, 407-303-7192, desiree.serr1@adventhealth.com
- Not yet recruiting
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15224
Adrienne DeRicco, 412-692-8069, adrienne.dericco2@upmc.edu
- Not yet recruiting
MaineHealth Pediatric Specialty Care
Portland, Maine, 04102
Rebecca Edwards, 207-662-6712, rebecca.edwards@mainehealth.org
- Recruiting
Adult Cystic Fibrosis Center at the University of Utah
Salt Lake City, Utah, 84112
Kristyn Packer, 801-520-5106, kristyn.packer@hsc.utah.edu
- Recruiting
Toledo Children's Hospital
Toledo, Ohio, 43606
Kelly Hoot, 419-291-4630, kelly.hoot@promedica.org
- Not yet recruiting
New York Medical College at Westchester Medical Center
Valhalla, New York, 10595
Zachary Messer, 914-594-2352, Zachary_Messer@nymc.edu
About this study
Official title: 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.
- Being tested
- ANG003 Dose A, ANG003 Dose B, Creon
- Keywords
- Cystic Fibrosis (CF), EPI
- Medical subject headings
- Exocrine Pancreatic Insufficiency, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANG003 Dose ADrug
160,000 u* lipase, 105,000 u* protease, and 11,600 u* amylase per dose (*units are comparable to United States Pharmacopeiea [USP])
ANG003 Dose BDrug
240,000 u* lipase, 105,000 u* protease, and 11,600 u* amylase per dose (*units are comparable to United States Pharmacopeiea [USP])
CreonDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| ANG003 Dose A | Experimental | 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. Receives: Drug: ANG003 Dose A |
| ANG003 Dose B | Experimental | 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. Receives: Drug: ANG003 Dose B |
| Creon | Active comparator | 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. Receives: Drug: Creon |
| Off Enzyme | No intervention | 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. |
| 60% to <80% CFA ANG003 Dose B | Other | 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. Receives: Drug: ANG003 Dose B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values
Adverse events (AEs); Treatment-emergent AEs; Serious AEs; Discontinuation due to AEs; Clinical laboratory values
Measured: From Visit 1 to Visit 5, anticipated average 80 days
Coefficient of Fat Absorption (CFA)
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%.
Measured: Period A (baseline) and Period B 72 hour CFA collection
Secondary outcomes (5)
Plasma docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) (ug/mL)
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Measured: Period A (baseline) and Period B time 0, 1, 2, 4, 6, 8, 10 and 24 hour collections
Coefficient of Nitrogen Absorption (CNA)
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Measured: Period A (baseline) and Period B 72 hour CNA collection
% of subjects with GI symptoms
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Measured: From Visit 2 to Visit 5, anticipated average 59 days
Cumulative stool weight
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Measured: Period A (baseline) and Period B 72 hour collection
Number of Stools per Day
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Measured: Period A (baseline) and Period B 72 hour collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start24 Apr 2026
- Primary completionJul 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exocrine Pancreatic Insufficiency (EPI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 113 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anagram Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07450547
- Sponsor's protocol ID
- ANG003-25-201
- Other IDs
- 2025-524569-25-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07450547
- Acronym / sponsor ID
- ANG003-25-201
- Keywords
- Cystic Fibrosis (CF), EPI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 113 participants (estimated)
- Lead sponsor
- Anagram Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| ANG003 Dose A | Experimental | Drug: ANG003 Dose AAll 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. |
| ANG003 Dose B | Experimental | Drug: ANG003 Dose BAll 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. |
| Creon | Active comparator | Drug: CreonAll 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. |
| Off Enzyme | No intervention | –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. |
| 60% to <80% CFA ANG003 Dose B | Other | Drug: ANG003 Dose BAll 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ANG003 Dose A160,000 u* lipase, 105,000 u* protease, and 11,600 u* amylase per dose (*units are comparable to United States Pharmacopeiea [USP]) | Drug | ANG003 Dose A |
| ANG003 Dose B240,000 u* lipase, 105,000 u* protease, and 11,600 u* amylase per dose (*units are comparable to United States Pharmacopeiea [USP]) | Drug | 60% to <80% CFA ANG003 Dose B, ANG003 Dose B |
| CreonThe 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. | Drug | Creon |
Primary outcome
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
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%.
5 secondary outcomes
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
Coefficient of Nitrogen Absorption (CNA)
Time frame: 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
Cumulative stool weight
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
Related trials for Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
RecruitingObservational study
Cancer in Inherited Bone Marrow Failure Syndromes
Diamond Blackfan Anemia, Dyskeratosis Congenita
Active, not recruiting
Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
Multi Organ Failure, Exocrine Pancreatic Insufficiency
RecruitingObservational study
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
Exocrine Pancreatic Insuficiency
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
27 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ANG003 Dose A, ANG003 Dose B and Creon in people with Exocrine Pancreatic Insufficiency (EPI) and Cystic Fibrosis (CF), run by Anagram Therapeutics, Inc. at 27 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evan Bailey, MD (617-466-3111, medical@anagramtx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.