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NCT06052293CompletedPhase 1

Phase 1 Study to Assess Safety and Efficacy of ANG003

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

Source: ClinicalTrials.gov · Last updated 27 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
57 (actual)
First submitted
9 Aug 2023
Start date
25 Aug 2023
Primary completion date
8 Jul 2024
Lead sponsor
Anagram Therapeutics, Inc.
NCT number
NCT06052293

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 57
  • From 25 Aug 2023 to the primary completion date, 8 Jul 2024
  • 20 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2).

Other illness

  • 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.

Other

  • 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.
  • Subjects who cannot discontinue omega-3 supplements \>500 mg of DHA and EPA daily.
  • Subjects unable to tolerate missing a dose of PERT.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (20)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Akron Childrens Hospital
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AkronUnited StatesUnknown status
Albany Medical College
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AlbanyUnited StatesUnknown status
University of Michigan Medical Center
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Ann ArborUnited StatesUnknown status
Massachusetts General Hospital
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BostonUnited StatesUnknown status
Boston Children's Hospital
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BostonUnited StatesUnknown status
University of Cincinnati
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CincinnatiUnited StatesUnknown status
University Hospitals of Cleveland Medical Center
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ClevelandUnited StatesUnknown status
Nationwide Children's Hospital
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ColumbusUnited StatesUnknown status
University of Texas Southwestern Medical Center
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DallasUnited StatesUnknown status
National Jewish Health
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DenverUnited StatesUnknown status
Harper University Hospital / Wayne State University
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DetroitUnited StatesUnknown status
Dartmouth Hitchcock Medical Center
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LebanonUnited StatesUnknown status
University of Arkansas for Medical Sciences
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Little RockUnited StatesUnknown status
Long Beach Memorial Medical Center
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Long BeachUnited StatesUnknown status
Norton Children's Research Institute/Affiliated with University of Louisville School of Medicine
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LouisvilleUnited StatesUnknown status
Medical College of Wisconsin
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MilwaukeeUnited StatesUnknown status
University of Minnesota
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MinneapolisUnited StatesUnknown status
UPMC Children's Hospital of Pittsburgh
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PittsburghUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
New York Medical College at Westchester Medical Center
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ValhallaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.