A Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose Beads Formulation in Subjects With a Pathological Oral Glucose Tolerance Test

NCT05803772 | Completed Phase 2 FDA Drug

• 1 other identifier: CAP2022-1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 3

Brief Summary

The primary purpose of the study is to evaluate the efficacy and safety of APHD-012 (distal jejunal-release dextrose \[Aphaia technology, AT\]) in participants with pre-diabetes (pathological Oral Glucose Tolerance Test (OGTT)).

Conditions

PreDiabetes; Glucose Tolerance Impaired

Keywords

OGTT; Glucose Tolerance; Prediabetes

Outcome Measures

Primary Outcomes (1)

• Change from baseline in AUC0-2h values of Oral Glucose Tolerance Test (OGTT) as measured in blood samples

  The primary efficacy endpoint is the change from baseline in AUC0-2h values of Oral Glucose Tolerance Test (OGTT) measured in blood samples at the end of each study period (Day 42 and Day 112, respectively). Two baselines will be defined for each period separately (Day 1 and Day 71, respectively).

  Day 1 to Day 42; Day 71 to Day 112

Secondary Outcomes (3)

• Change from baseline in fasting plasma glucose concentrations

  Day 1 to Day 42; Day 71 to Day 112

• Change from baseline in HOMA IR

  Day 1 to Day 42; Day 71 to Day 112

• Number of Participants Reported with At least One Treatment Emergent Adverse Event (TEAE)

  Day 1 to Day 42; Day 71 to Day 112

Other Outcomes (12)

• Change in systolic blood pressure (SBP)

  Day 1 to Day 42; Day 71 to Day 112

• Change from baseline in Diastolic blood pressure (DBP)

  Day 1 to Day 42; Day 71 to Day 112

• Change from baseline in Heart rate (HR)

  Day 1 to Day 42; Day 71 to Day 112

Study Arms (2)

Active to Placebo Cross

OTHER

Participants will first receive a single dose of APHD-012 12 g daily, under fasting conditions prior to main daily meals for 6 weeks (day 1-42), followed by washout period of 4 weeks (day 43-70), and subsequent crossover to the other treatment APH-012P for 6 weeks (day 71-112).

Drug: APHD-012; Drug: APH-012P

Placebo to Active Cross

OTHER

Participants will first receive a single dose of APH-012P daily, under fasting conditions prior to main daily meals for 6 weeks (day 1-42), followed by washout period of 4 weeks (day 43-70), and subsequent crossover to the other treatment APHD-012 12 g for 6 weeks (day 71-112).

Drug: APHD-012; Drug: APH-012P

Interventions

APHD-012 DRUG

Drug: APHD-012 Distal jejunal-release dextrose beads (Aphaia technology, AT)

Also known as: Distal jejunal-release dextrose beads

Active to Placebo Cross; Placebo to Active Cross

APH-012P DRUG

Distal jejunal-release placebo beads

Also known as: Placebo

Active to Placebo Cross; Placebo to Active Cross

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female subjects 18 - 70 years of age
• Fully vaccinated against SARS-CoV-2.
• Body mass index 25-35 kg/m2
• Subjects with an impaired glucose tolerance defined as: HbA1c values ≥5.7% and ≤ 6.4%, and/or, Impaired glucose tolerance (glucose between 140 and 199 mg/dL at the 2 hours of the Oral Glucose Tolerance Test (OGTT)) with or without impaired fasting glucose (fasting glucose between 100 and 125 mg/dL)
• Stable body weight: gain or loss in body weight ≤ 5% body weight over last 3 months
• History of at least one unsuccessful effort of lifestyle modification to loose \>5% of body weight, completed at least 3 months prior to screening. Subject may have been treated with either diet or exercise alone.
• Willingness to undergo screening and all study procedures and examinations (i.e., physical examinations and laboratory investigations before and after the treatment periods) and to wear a flash glucose monitoring device.
• Ability to comprehend subject information and willingness to sign the informed consent.

You may not qualify if:

• Evidence of type 2 diabetes defined by fasting plasma glucose ≥ 126 mg/dL; 2-hour OGTT glucose ≥ 200 mg/dL
• Type I diabetes mellitus
• HbA1c ≥ 6.5%
• History of proliferative retinopathy or maculopathy
• Active COVID-19 infection proven by antigen positive Covid Test
• Treatment with any medication for weight loss within the past 3 months before screening.
• Prior or planned weight loss surgery for obesity
• Recent (within past 12 months) or planned endoscopic treatment for obesity.
• Proven history of bulimia or anorexia nervosa
• Eating habits consisting of eating relevant amounts of food throughout the night (after 10 p.m.; except if working on night shifts)
• Treatment with injectable anti-diabetic medications in the last 3 months (e.g., GLP-1 receptor agonists, insulin)
• Treatment with dipeptidyl peptidase-4 inhibitors in the last 3 months
• Confirmed medical history of liver cirrhosis
• Positive test on Viral hepatitis (HbsAG, HCV)
• Positive test on Human immunodeficiency virus (HIV)

Sponsors & Collaborators

• Aphaia Pharma US LLC: lead

Study Sites (3)

Cell-B s.r.o.

Levice, Slovenska, 93405, Slovakia

Location

ALIAN, s.r.o.

Bardejov, Slovakia

Location

MEDISPEKTRUM s.r.o.

Bratislava, Slovakia

Location

MeSH Terms

Conditions

Prediabetic State; Glucose Intolerance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 7, 2023
• Study Start: March 31, 2023
• Primary Completion: February 12, 2024
• Study Completion: February 12, 2024
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SL (3)