Clinical trial

A Study of Distal Jejunal-release Dextrose in Obese Participants

Active, not recruiting · Phase 2 · 3 countries · Registry ID NCT05385978

Active, not recruitingPhase 2Interventional

What this study is about

The primary purpose of the study is to evaluate the efficacy and safety of APHD-012 (distal jejunal-release dextrose \[Aphaia technology, AT\]) in obese participants.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 70 Years
SexAll
Healthy volunteersNot accepted
ConditionObese

Full registry criteria

Inclusion Criteria: * Body mass index 30.0-39.9 kg/m\^2 and/or waist circumference: men \>102 cm, women \>88 cm * Stable body weight: gain or loss in body weight ≤5 kg over last 3 months * Obese participants with or without one or more of the following conditions: 1. NAFLD - simple steatosis based on a FibroScan CAP™ test result at screening (CAP Score ≥238 decibel-milliwatts (dB/m) (Steatosis Grades 1-3) with no or mild fibrosis (F0-F1 fibrosis Score) 2. NASH - steatohepatitis based on FibroScan fibrosis Score at screening (≥7.5 kPa and \<14 kPa (Stage F2-F3) 3. Confirmed medical history of metabolic syndrome 4. Homeostatic Model Assessment of Insulin Resistance (HOMA IR) Score ≥2 5. Confirmed medical history of type 2 diabetes mellitus (T2DM) diagnosis or HbA1c ≥7.0 and \<11 (based on screening values) 6. High total cholesterol ≥240 mg/dL (based on screening values) 7. Hypertension (participants with Stage 1 hypertension (systolic blood pressure \[SBP\] ≥130 mmHg \<180 mmHg, diastolic blood pressure \[DBP\] ≥80 mmHg \<110 mmHg) (based on screening values) * If on medication to manage endocrine/metabolic conditions, must be on stable doses of medication ≥3 months prior to screening: 1. Participants with T2DM may be treated with either diet and exercise alone, metformin, sulphonylurea, thiazolidinediones, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, and bromocriptine quick-release (QR) as single agents or combination therapy. 2. As lipid-lowering medication participants may be treated with statins and fibrates, proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, ezetimibe, or supplements like omega-3-fatty acids. 3. As antihypertensive medication participants may be treated with beta-blockers, angiotensin-converting enzyme (ACE) inhibitors, angiotensin-II-inhibitors, diuretics, or calcium channel blockers. * Normal GI function, or abnormalities which the clinical investigator does not consider a disqualification for participation in the study Exclusion Criteria: * Incomplete Coronavirus Disease of 2019 (COVID-19) vaccination * Treatment with weight loss medications in the past 3 months * Proven history of bulimia or anorexia nervosa * Treatment with injectable antidiabetic medications in the last 3 months (e.g. Glucagon-like peptide-1 \[GLP-1\] receptor agonists, insulin) * Treatment with dipeptidyl peptidase-4 inhibitors in the last 3 months * NASH with cirrhosis (fibrosis Score=F4 (≥14 kPa) as determined by screening FibroScan * Confirmed medical history of liver cirrhosis, cholestatic disease, alcohol-related liver disease * Type 1 diabetes mellitus, HbA1c ≥11, fasting plasma glucose levels ≥270 mg/dL * Proliferative retinopathy or maculopathy * Abnormal liver function tests: 1. Transaminases: * Alanine transaminase (ALT)/aspartate aminotransferase (AST) ≥5 x upper limit of normal (ULN) for participants with NAFLD or NASH (as determined by screening FibroScan) * ALT/AST ≥2.5 x ULN for participants without NAFLD or NASH (as determined by screening FibroScan) 2. Alkaline phosphatase (ALK) ≥2.5 x ULN 3. Total bilirubin ≥2 x ULN * Stage 4 hypertension (SBP ≥180, DBP ≥110) * History or presence of any uncontrolled cardiovascular, pulmonary, hepatobiliary, renal, hematologic, gastrointestinal, endocrinologic, immunologic, dermatologic, neurological, psychiatric, metabolic, musculoskeletal, or malignant disease (except conditions accepted for inclusion) which the clinical investigator does not consider a disqualification for participation in the study

Treatments and study arms

APHD-012

Drug

Distal jejunal-release dextrose beads (Aphaia technology, AT)

APHD-012P

Drug

Distal jejunal-release placebo beads

Primary outcomes

Changes from Baseline in Percent Weight Change Compared with PlaceboAt Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1

Bodyweight measurements will be done using standard personal balance referring to kilogram-Scale. Weighing will be done without shoes and with just underwear on. It is important that weighing is always done in the same way, preferably in the morning, before eating or drinking.

Study locations

9 locations were listed when this page was built. The first 40 are shown.

LTD "Acad. G. Chapidze Emergency Cardiology Center"🌐 Tbilisi, Georgia
LTD "Diacor"🌐 Tbilisi, Georgia
LTD "Israeli-Georgian Medical Research Clinic Healthycore"🌐 Tbilisi, Georgia
LTD "National Institute of Endocrinology"🌐 Tbilisi, Georgia
LTD "Tbilisi Heart Center"🌐 Tbilisi, Georgia
Universitätsklinikum Schleswig-Holstein🇩🇪 Lübeck, Germany
Universitätsklinikum Ruppin-Brandenburg🇩🇪 Neuruppin, Germany
FDI Clinical Research🇵🇷 San Juan, Puerto Rico
GCM Medilcal Group🇵🇷 San Juan, Puerto Rico