Exocrine Pancreatic InsufficiencyPhase 1NCT06052293
Phase 1 Study to Assess Safety and Efficacy of ANG003
A Phase 1 study testing ANG003 in people with Exocrine Pancreatic Insufficiency, run by Anagram Therapeutics, Inc. at 20 sites in United States.
Trial summary
Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency. The study's overall objectives are to evaluate the safety, tolerability and effect of four dose levels of ANG003. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exocrine Pancreatic Insufficiency
- What is being tested?
- ANG003
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 20 sitesUnited States
- Study dates
- 25 Aug 2023to 8 Jul 2024
- Phase
- Phase 1
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects 18 years of age or older.
- Confirmed diagnosis of CF defined as: a) CF signs and symptoms AND b) Two CF-causing mutations on genetic testing or sweat chloride >60 mEq/L.
- Documented history of fecal elastase <100 µg/g stool.
- EPI clinically controlled with minimal clinical symptoms and on a stable dose of PERT for 90 days before screening as determined by the Investigator.
- Adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects.
Who cannot join
- Subjects with diabetes mellitus who are unable to refrain from short-acting and rapid-acting insulin on Days 1 and 5 for a daily total of 6 hours.
- Involuntary loss of ≥10% of usual body weight within last 6 months or involuntary loss of >5% of body weight within 1 month.
- Requires use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration.
- CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2).
- Subjects who cannot discontinue omega-3 supplements >500 mg of DHA and EPA daily.
- Subjects unable to tolerate missing a dose of PERT.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Akron Childrens Hospital
Akron, Ohio, 44308
Albany Medical College
Albany, New York, 12208
University of Michigan Medical Center
Ann Arbor, Michigan, 48109
Massachusetts General Hospital,
Boston, Massachusetts, 02114
Boston Children's Hospital
Boston, Massachusetts, 02115
University of Cincinnati
Cincinnati, Ohio, 45267
University Hospitals of Cleveland Medical Center
Cleveland, Ohio, 44106
Nationwide Children's Hospital
Columbus, Ohio, 43205
University of Texas Southwestern Medical Center
Dallas, Texas, 75235
National Jewish Health
Denver, Colorado, 80206
Harper University Hospital / Wayne State University
Detroit, Michigan, 48201
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Long Beach Memorial Medical Center
Long Beach, California, 90806
Norton Children's Research Institute affiliated with University of Louisville School of Medicine
Louisville, Kentucky, 40202
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
UPMC Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224
University of Utah
Salt Lake City, Utah, 84132
New York Medical College at Westchester Medical Center
Valhalla, New York, 10595
About this study
Official title: A Phase 1 Open-Label, Multicenter Study to Assess the Safety and Efficacy of ANG003 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency. The study's overall objectives are to evaluate the safety, tolerability and effect of four dose levels of ANG003.
Read the detailed description
The Phase 1 study was designed to compare a 24h Baseline Substrate Absorption Challenge Test (SACT) period with no enzymes to a 24h ANG003 SACT period with enzymes. Eligible subjects will be randomly assigned with equal allocation to one of four active dose levels of lipase, protease and amylase. Approximately 48 to 60 eligible subjects are planned to be enrolled in the study with 12 to 15 subjects assigned to each dose level from up to 21 investigational sites.
- Conditions
- Exocrine Pancreatic Insufficiency
- Being tested
- ANG003
- Keywords
- Cystic Fibrosis
- 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.
ANG003Drug
Also called Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.
To evaluate four possible combinations of lipase, protease and amylase.
| Study group | Role | What they receive |
|---|---|---|
| ANG003 Dose Level 1 | Experimental | Single administration dose contains 20 mg lipase, 25 mg protease and 40 mg amylase. Receives: Drug: ANG003 |
| ANG003 Dose Level 2 | Experimental | Single administration dose contains 40 mg lipase, 50 mg protease and 80 mg amylase. Receives: Drug: ANG003 |
| ANG003 Dose Level 3 | Experimental | Single administration dose contains 80 mg lipase, 50 mg protease and 80 mg amylase. Receives: Drug: ANG003 |
| ANG003 Dose Level 4 | Experimental | Single administration dose contains 120 mg lipase, 75 mg protease and 120 mg amylase. Receives: Drug: ANG003 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and AEs Leading to Study Discontinuation
AE, SAEs and AEs leading to study discontinuation measured by number of participants during study.
Measured: Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start25 Aug 2023
- Primary completion8 Jul 2024
- Study completion8 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Exocrine Pancreatic InsufficiencyStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anagram Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meghana Sathe, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06052293
- Sponsor's protocol ID
- ANG003-22-101
- Status last verified
- Apr 2026
- First submitted
- 9 Aug 2023
- Last updated
- 27 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No