A Phase 2 interventional study of ANG003 Dose A and ANG003 Dose B in Exocrine Pancreatic Insufficiency (EPI) and Cystic Fibrosis (CF), sponsored by Anagram Therapeutics, Inc.. Recruiting at 28 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.
Sponsored by Anagram Therapeutics, Inc. · Phase 2, Interventional, and Treatment
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.
136 studies on the registry are indexed under Exocrine Pancreatic Insufficiency; 26 are open to participants now.
This study's planned enrollment of 113 is above the median of 40 across 94 interventional studies indexed under Exocrine Pancreatic Insufficiency.
Browse Exocrine Pancreatic Insufficiency studies →Anagram Therapeutics, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Adequate nutritional status measured by (BMI) defined by:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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.
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
160,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
240,000 u\* lipase, 105,000 u\* protease, and 11,600 u\* amylase per dose (\*units are comparable to United States Pharmacopeiea \[USP\])
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.
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
Time frame: 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%.
Time frame: Period A (baseline) and Period B 72 hour CFA collection
Plasma docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA) (ug/mL)
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
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)
Mean change from baseline for each treatment group amongst subjects with baseline CFA ≥80%.
Time frame: 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%.
Time frame: 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%.
Time frame: 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%.
Time frame: Period A (baseline) and Period B 72 hour collection
Correlation between DHA/EPA and CFA
Mean change from baseline for each treatment group with a baseline CFA ≥80%
Time frame: 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)
Mean change from baseline for each treatment group with a baseline CFA 60% to \<80%
Time frame: 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%
Period B CFA Off Enzyme in subjects with a baseline CFA ≥80%
Time frame: Period B 72 hour CFA collection
Started Apr 2026 (actual). Primary completion is estimated for Jul 2027, 15 months after the start.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Exocrine Pancreatic Insufficiency →
Anagram Therapeutics, Inc.