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ANG003 for Pancreatic Insufficiency

Phase 1
Recruiting
Led By Meghana Sathe, MD
Research Sponsored by Anagram Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Adequate nutritional status measured by body mass index ≥20kg/m2 for adult subjects
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed through study completion, up to 9 days (day 1 thru day 9).
Awards & highlights

Study Summary

This trial tests how safe and effective a new medication is for adults with cystic fibrosis-related pancreatic insufficiency. It also evaluates 4 different dose levels.

Who is the study for?
Adults with cystic fibrosis-related exocrine pancreatic insufficiency (EPI) who have been stable on enzyme replacement therapy for 90 days, have a BMI ≥20kg/m2, and show specific diagnostic criteria for CF. Not eligible if they've had recent weight loss or exacerbations, need certain feeding tubes, can't stop omega-3 supplements over 500 mg daily, or can't skip insulin or PERT doses as required by the study.Check my eligibility
What is being tested?
The trial is testing ANG003's safety and effectiveness when taken orally with a meal in adults with EPI due to cystic fibrosis. Participants will receive one of four different dose levels of ANG003 to see how well it works and how safe it is compared to their usual treatments.See study design
What are the potential side effects?
As this is a Phase 1 trial primarily focused on safety and tolerability, potential side effects are being investigated but may include digestive discomfort, allergic reactions to the new medication ANG003, changes in blood sugar levels especially in diabetic patients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have cystic fibrosis confirmed by genetic tests or a sweat test.
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My BMI is 20 or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed through study completion, up to 9 days (day 1 thru day 9).
This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed through study completion, up to 9 days (day 1 thru day 9). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse Events (AE), Serious Adverse Events (SAE), and AEs Leading to Study Discontinuation
Malabsorption Symptoms
Secondary outcome measures
Carbohydrate Absorption
Fat Absorption
Protein Absorption

Trial Design

4Treatment groups
Experimental Treatment
Group I: ANG003 Dose Level 4Experimental Treatment1 Intervention
Single administration dose contains 6x lipase, 3x protease and 3x amylase starting dose.
Group II: ANG003 Dose Level 3Experimental Treatment1 Intervention
Single administration dose contains 4x lipase, 2x protease and 2x amylase starting dose.
Group III: ANG003 Dose Level 2Experimental Treatment1 Intervention
Single administration dose contains 2x lipase, 2x protease and 2x amylase starting dose.
Group IV: ANG003 Dose Level 1Experimental Treatment1 Intervention
Single administration starting dose contains lipase, protease and amylase.

Find a Location

Who is running the clinical trial?

Anagram Therapeutics, Inc.Lead Sponsor
Meghana Sathe, MDPrincipal InvestigatorUniversity of Texas
1 Previous Clinical Trials
402 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the limit of participants for this clinical research?

"Affirmative. The study is currently recruiting, as indicated by clinicaltrials.gov which dates the trial's posting to August 25th 2023 and last edit on September 18th 2023. Sixty participants need to be enrolled from 1 site for this medical research opportunity."

Answered by AI

Are there any vacancies within this experiment open to participants?

"According to the information available on clinicaltrials.gov, this trial is in search of participants and was originally posted on August 25th 2023 with its most recent update being issued on September 18th 2023."

Answered by AI

What sort of safety measures have been taken to ensure ANG003 Dose Level 1 is suitable for patient use?

"Due to the limited evidence of safety and efficacy, our team at Power gave ANG003 Dose Level 1 a score of one out of three."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase 1 Study to Assess Safety and Efficacy of ANG003
2023. "Phase 1 Study to Assess Safety and Efficacy of ANG003". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06052293.
~36 spots leftby Apr 2025
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