Phase 1 Study to Assess Safety and Efficacy of ANG003

April 23, 2026 updated by: Anagram Therapeutics, Inc.

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.

Study Overview

Status

Status

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

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.

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.

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 (Actual)

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.
57

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 1

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 Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Health
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Children's Research Institute affiliated with University of Louisville School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Boston Children's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital,
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Medical Center
      • Detroit, Michigan, United States, 48201
        • Harper University Hospital / Wayne State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College
      • Valhalla, New York, United States, 10595
        • New York Medical College at Westchester Medical Center
    • Ohio
      • Akron, Ohio, United States, 44308
        • Akron Childrens Hospital
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cleveland, Ohio, United States, 44106
        • University Hospitals of Cleveland Medical Center
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • UPMC Children's Hospital of Pittsburgh
    • Texas
      • Dallas, Texas, United States, 75235
        • University of Texas Southwestern Medical Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Medical College of Wisconsin

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male and female subjects 18 years of age or older.
  2. 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.
  3. Documented history of fecal elastase <100 µg/g stool.
  4. EPI clinically controlled with minimal clinical symptoms and on a stable dose of PERT for 90 days before screening as determined by the Investigator.
  5. Adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects.

Exclusion Criteria:

  1. 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.
  2. Involuntary loss of ≥10% of usual body weight within last 6 months or involuntary loss of >5% of body weight within 1 month.
  3. Requires use of naso-gastric, J-tube, G-tube, and/or enteral feeding for the study duration.
  4. CF pulmonary exacerbation within 30 days prior to the Baseline SACT Period (Visit 2).
  5. Subjects who cannot discontinue omega-3 supplements >500 mg of DHA and EPA daily.
  6. Subjects unable to tolerate missing a dose of PERT.

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: None (Open Label)

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 Level 1
Single administration dose contains 20 mg lipase, 25 mg protease and 40 mg amylase.
Drug: ANG003
To evaluate four possible combinations of lipase, protease and amylase.
Other Names:
  • Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.
Experimental: ANG003 Dose Level 2
Single administration dose contains 40 mg lipase, 50 mg protease and 80 mg amylase.
Drug: ANG003
To evaluate four possible combinations of lipase, protease and amylase.
Other Names:
  • Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.
Experimental: ANG003 Dose Level 3
Single administration dose contains 80 mg lipase, 50 mg protease and 80 mg amylase.
Drug: ANG003
To evaluate four possible combinations of lipase, protease and amylase.
Other Names:
  • Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.
Experimental: ANG003 Dose Level 4
Single administration dose contains 120 mg lipase, 75 mg protease and 120 mg amylase.
Drug: ANG003
To evaluate four possible combinations of lipase, protease and amylase.
Other Names:
  • Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.

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
Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and AEs Leading to Study Discontinuation
Time Frame: Assessed through study completion, up to 9 days (Day 1 thru Day 9).
AE, SAEs and AEs leading to study discontinuation measured by number of participants during study.
Assessed through study completion, up to 9 days (Day 1 thru Day 9).

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
Fat Absorption
Time Frame: Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Measured by concentration and percent of plasma fatty acids.
Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Protein Absorption
Time Frame: Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Measured by changes in plasma concentration of amino acids.
Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Carbohydrate Absorption
Time Frame: Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Changes in glucose (mg/dL) as measured by continuous glucose monitoring.
Assessed through study completion, up to 9 days (Day 1 thru Day 9).

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
Malabsorption Symptoms
Time Frame: Acute PAGI-SYM is based upon 7-day recall.
Severity of malabsorption symptoms (e.g., abdominal discomfort or pain, bloating, heartburn, regurgitation or reflux, retching, stomach fullness, and vomiting) by patient reported outcome scale (0=None; 1=Very Mild; 2=Mild; 3=Moderate; 4=Severe; 5=Very Severe). Measured by 20 questions contained in Acute Patient Assessment of Gastrointestinal Symptoms (Acute PAGI-SYM) questionnaire.
Acute PAGI-SYM is based upon 7-day recall.
Protein Absorption
Time Frame: Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Measured by changes in plasma concentration of amino acids.
Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Carbohydrate Absorption
Time Frame: Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Changes in glucose (mg/dL) as measured by continuous glucose monitoring.
Assessed through study completion, up to 9 days (Day 1 thru Day 9).
Fat Absorption Assessed as Cmax of DHA+EPA
Time Frame: DHA+EPA measured at baseline t0, 1h, 2h, 4h, 6h, 8h, 10-12h, and 24h post on Baseline SACT (Day 1) and ANG003 SACT (Day 5)
Measured by concentration of plasma fatty acids.
DHA+EPA measured at baseline t0, 1h, 2h, 4h, 6h, 8h, 10-12h, and 24h post on Baseline SACT (Day 1) and ANG003 SACT (Day 5)
Fat Absorption Assessed as Area Under the Curve (AUC-24hr) of Plamsa Docosahexaenoic Acid (DHA) and Eicosapentaenoic Acid (EPA)
Time Frame: DHA+EPA measured at baseline t0, 1h, 2h, 4h, 6h, 8h, 10-12h, and 24h post on Baseline SACT (Day 1) and ANG003 SACT (Day 5)
Measured by concentration of plasma fatty acids.
DHA+EPA measured at baseline t0, 1h, 2h, 4h, 6h, 8h, 10-12h, and 24h post on Baseline SACT (Day 1) and ANG003 SACT (Day 5)

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.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Meghana Sathe, MD, University of Texas

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.
August 25, 2023

Primary Completion (Actual)

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 8, 2024

Study Completion (Actual)

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 8, 2024

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).
August 9, 2023

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.
September 18, 2023

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.
September 25, 2023

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.
April 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.
April 23, 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.
April 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.
  • ANG003-22-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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