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Phase 1 Study to Assess Safety and Efficacy of ANG003

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06052293
Recruitment Status : Recruiting
First Posted : September 25, 2023
Last Update Posted : January 5, 2024
Sponsor:
Information provided by (Responsible Party):
Anagram Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE August 9, 2023
First Posted Date  ICMJE September 25, 2023
Last Update Posted Date January 5, 2024
Actual Study Start Date  ICMJE August 25, 2023
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 18, 2023)
  • 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, SAE, and AEs leading to study discontinuation measured by frequency and severity during study.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 18, 2023)
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase 1 Study to Assess Safety and Efficacy of ANG003
Official Title  ICMJE 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
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open-label
Primary Purpose: Treatment
Condition  ICMJE Exocrine Pancreatic Insufficiency
Intervention  ICMJE Drug: ANG003
To evaluate four possible combinations of lipase, protease and amylase.
Other Name: Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 4.
Study Arms  ICMJE
  • Experimental: ANG003 Dose Level 1
    Single administration starting dose contains lipase, protease and amylase.
    Intervention: Drug: ANG003
  • Experimental: ANG003 Dose Level 2
    Single administration dose contains 2x lipase, 2x protease and 2x amylase starting dose.
    Intervention: Drug: ANG003
  • Experimental: ANG003 Dose Level 3
    Single administration dose contains 4x lipase, 2x protease and 2x amylase starting dose.
    Intervention: Drug: ANG003
  • Experimental: ANG003 Dose Level 4
    Single administration dose contains 6x lipase, 3x protease and 3x amylase starting dose.
    Intervention: Drug: ANG003
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 18, 2023)		 60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 24, 2024
Estimated Primary Completion Date January 31, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maria Basco, MD, MPH 630.863.1761 maria.basco@ssistrategy.com
Contact: Marcie Clarkin, RN,BS 617.466.3111 mclarkin@anagramtx.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT06052293
Other Study ID Numbers  ICMJE ANG003-22-101
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Anagram Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Anagram Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Meghana Sathe, MD University of Texas
PRS Account Anagram Therapeutics, Inc.
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP