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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Changes from Baseline in Percent Weight Change Compared with Placebo — At 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.
Trial sites (9)
Facility
City
Region
Status
LTD "Israeli-Georgian Medical Research Clinic Healthycore"
Tbilisi
Georgia
LTD "Acad. G. Chapidze Emergency Cardiology Center"
Tbilisi
Georgia
LTD "Diacor"
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
GCM Medilcal Group
San Juan
Puerto Rico
FDI Clinical Research
San Juan
Puerto Rico
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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