ObesePhase 2NCT05385978
A Study of Distal Jejunal-release Dextrose in Obese Participants
A Phase 2 study testing APHD-012 and APHD-012P in people with Obese, run by Aphaia Pharma US LLC at 9 sites in 3 countries.
Trial 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 obese participants. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Obese
- What is being tested?
- APHD-012 and APHD-012P
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 9 sitesin 3 countries
- Study dates
- 1 Nov 2022to 11 Nov 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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)
- NASH - steatohepatitis based on FibroScan fibrosis Score at screening (≥7.5 kPa and <14 kPa (Stage F2-F3)
- Confirmed medical history of metabolic syndrome
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- Homeostatic Model Assessment of Insulin Resistance (HOMA IR) Score ≥2
- Confirmed medical history of type 2 diabetes mellitus (T2DM) diagnosis or HbA1c ≥7.0 and <11 (based on screening values)
- High total cholesterol ≥240 mg/dL (based on screening values)
- 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:
- 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.
- 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.
- 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
Who cannot join
- 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
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- 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:
- 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)
- Alkaline phosphatase (ALK) ≥2.5 x ULN
- 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
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
Georgia5 sites
LTD "Israeli-Georgian Medical Research Clinic Healthycore"
Tbilisi, 0112
LTD "Acad. G. Chapidze Emergency Cardiology Center"
Tbilisi, 0159
LTD "Diacor"
Tbilisi, 0159
LTD "National Institute of Endocrinology"
Tbilisi, 0159
LTD "Tbilisi Heart Center"
Tbilisi, 0186
Germany2 sites
Universitätsklinikum Schleswig-Holstein
Lübeck, 23538
Universitätsklinikum Ruppin-Brandenburg
Neuruppin, 16816
Puerto Rico2 sites
GCM Medilcal Group
San Juan, 00917-3104
FDI Clinical Research
San Juan
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose (Aphaia Technology, AT) in Obese Subjects
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.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, phase II proof-of-concept study to be conducted in 150 adult obese male and female participants who are 18 to 70 years of age with or without one or more endocrine and/or metabolic conditions. The study aims to evaluate the efficacy and safety of distal jejunal-release dextrose (Aphaia technology, AT) in obese participants.
Participants will be randomly assigned to receive either APHD-012 (distal jejunal-release dextrose or APH-012P (a matching placebo). There will be two cohorts in the study. Participants from Cohort 1 will receive study medication once daily for 12 months (360 days), and participants from Cohort 2 will receive study medication once daily for 6 months (180 days).
Overall, 150 participants will be enrolled in the study:
- Cohort 1 (60 participants) - 6-month treatment period + 6-month maintenance treatment period
- Cohort 2 (90 participants) - 6-month treatment period
- Conditions
- Obese
- Being tested
- APHD-012, APHD-012P
- Keywords
- Obese, Dextrose, Hypertension, NASH, 034B20, Distal jejunal-release dextrose, Endocrine disorders, Metabolic conditions, NAFLD
- Medical subject headings
- Obesity, Hypertension, Endocrine System Diseases, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APHD-012Drug
Also called Distal jejunal-release dextrose beads
Distal jejunal-release dextrose beads (Aphaia technology, AT)
APHD-012PDrug
Also called Placebo
Distal jejunal-release placebo beads
| Study group | Role | What they receive |
|---|---|---|
| APHD-012 | Active comparator | Participants will receive a single dose of APHD-012 12 g daily, under fasting conditions prior to main daily meals for 180 days (6 months) for Cohort 2 and for 360 days (12 months) for Cohort 1. Receives: Drug: APHD-012 |
| APHD-012P | Placebo comparator | Participants will receive a single dose of APHD-012P daily, under fasting conditions prior to main daily meals for 180 days (6 months) for Cohort 2 and for 360 days (12 months) for Cohort 1. Receives: Drug: APHD-012P |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from Baseline in Percent Weight Change Compared with Placebo
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.
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Secondary outcomes (13)
Percentage of Participants with ≥2.5% Baseline Body Weight Loss at 6 Months Compared with Placebo (Weight Loss Responders)
Body weight 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.
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Percentage of Participants with ≥5% Baseline Body Weight Loss at 6 Months Compared with Placebo (Weight Loss Responders)
Body weight 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.
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
The Difference in Mean Absolute Weight Loss Compared with Placebo at 6 Months
Body weight 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.
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Waist Circumference
Waist circumference measurements will be done using a standard measuring tape referring to centimeter Scale.
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Systolic Blood Pressure and Diastolic Blood Pressure
Systolic blood pressure (SBP) and diastolic blood pressure (DBP) will be measured using a standard sphygmomanometer with the Riva-Rocci cuff and a stethoscope; alternatively, an automatic device with upper arm cuff can be used. Measurements are done in sitting position after 5 minutes of rest.
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Heart Rate
Heart rate measurement will be obtained along with the blood pressure measurement.
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Triglycerides and Cholesterol
Triglycerides and cholesterol (including total cholesterol, low-density lipoprotein [LDL], and high-density lipoprotein [HDL]) will be measured using standard clinical laboratory methods at the site laboratories.
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Homeostatic Model Assessment of Insulin Resistance
Homeostasis model assessment-estimated insulin resistance (HOMA-IR) will be determined with standard clinical laboratory methods.
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Fasting Plasma Glucose, Fasting Plasma Insulin and Glycated Hemoglobin
Fasting plasma glucose will be determined using a standard blood glucometer. Fasting plasma insulin will be determined with standard clinical laboratory methods. Glycated hemoglobin (HbA1c) will be measured using a standard enzyme-linked immunoassay (ELISA) method.
HbA1c will be measured in participants with type two diabetes (T2DM).
Measured: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Alanine Transaminase, Aspartate Transaminase and Gamma Glutamyl Transpeptidase
Liver enzymes (ALT, AST, GGT) will be measured using standard clinical laboratory methods.
Measured: At Baseline and at Day 90, at Day 180 for Cohort 2 and at Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Fatty Liver Controlled Attenuation Parameter Score and Liver Fibrosis Score
Fatty liver Controlled Attenuation Parameter (CAP) Score will be measured in:
- Participants with Non-alcoholic fatty liver disease (NAFLD): Steatosis grade and;
- Participants with Non-alcoholic steatohepatitis (NASH): fibrosis Score category
Fatty liver CAP Score and liver fibrosis Score will be measured using FibroScan™ equipment or equivalent.
Measured: At Baseline and at Day 90, at Day 180 for Cohort 2 and at Day 360 for Cohort 1
Number of Participants Reported with At least One Treatment Emergent Adverse Event (TEAE)
A treatment-emergent adverse event is defined as any event not present prior to the initiation of the drug treatment or any event already present that worsens in either intensity or frequency following exposure to the drug treatment
Measured: At each visit until Day 180 for Cohort 2 and until Day 360 for Cohort 1
Advance Understanding of Dose/Exposure - Response Relationships
Dose/Exposure - Response Relationships will be evaluated.
Measured: At Baseline, at Day 90, Day 180 and at Day 360 for Cohort 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Nov 2022
- Primary completion11 Nov 2024 (estimated)
- Study completion11 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObeseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment Randomized, double-blind, placebo-controlled, parallel-group proof-of-concept efficacy and safety study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aphaia Pharma US LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385978
- Sponsor's protocol ID
- 034B20
- Status last verified
- Oct 2024
- First submitted
- 13 May 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose (Aphaia Technology, AT) in Obese Subjects
- ClinicalTrials.gov ID
- NCT05385978
- Acronym / sponsor ID
- 034B20
- Conditions
- Obese
- Keywords
- Obese, Dextrose, Hypertension, NASH, 034B20, Distal jejunal-release dextrose, Endocrine disorders, Metabolic conditions
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Aphaia Pharma US LLCIndustry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 11 Nov 2024 (estimated)
- Study completion
- 11 Nov 2024 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, phase II proof-of-concept study to be conducted in 150 adult obese male and female participants who are 18 to 70 years of age with or without one or more endocrine and/or metabolic conditions. The study aims to evaluate the efficacy and safety of distal jejunal-release dextrose (Aphaia technology, AT) in obese participants.
Participants will be randomly assigned to receive either APHD-012 (distal jejunal-release dextrose or APH-012P (a matching placebo). There will be two cohorts in the study. Participants from Cohort 1 will receive study medication once daily for 12 months (360 days), and participants from Cohort 2 will receive study medication once daily for 6 months (180 days).
Overall, 150 participants will be enrolled in the study:
- Cohort 1 (60 participants) - 6-month treatment period + 6-month maintenance treatment period
- Cohort 2 (90 participants) - 6-month treatment period
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment Randomized, double-blind, placebo-controlled, parallel-group proof-of-concept efficacy and safety study
| Arm | Type | Receives |
|---|---|---|
| APHD-012 | Active comparator | Drug: APHD-012Participants will receive a single dose of APHD-012 12 g daily, under fasting conditions prior to main daily meals for 180 days (6 months) for Cohort 2 and for 360 days (12 months) for Cohort 1. |
| APHD-012P | Placebo comparator | Drug: APHD-012PParticipants will receive a single dose of APHD-012P daily, under fasting conditions prior to main daily meals for 180 days (6 months) for Cohort 2 and for 360 days (12 months) for Cohort 1. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
- If on medication to manage endocrine/metabolic conditions, must be on stable doses of medication ≥3 months prior to screening:
- Normal GI function, or abnormalities which the clinical investigator does not consider a disqualification for participation in the study
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APHD-012Also: Distal jejunal-release dextrose beadsDistal jejunal-release dextrose beads (Aphaia technology, AT) | Drug | APHD-012 |
| APHD-012PAlso: PlaceboDistal jejunal-release placebo beads | Drug | APHD-012P |
Primary outcome
Changes from Baseline in Percent Weight Change Compared with Placebo
Time frame: 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.
13 secondary outcomes
Percentage of Participants with ≥2.5% Baseline Body Weight Loss at 6 Months Compared with Placebo (Weight Loss Responders)
Time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Percentage of Participants with ≥5% Baseline Body Weight Loss at 6 Months Compared with Placebo (Weight Loss Responders)
Time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
The Difference in Mean Absolute Weight Loss Compared with Placebo at 6 Months
Time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Waist Circumference
Time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Systolic Blood Pressure and Diastolic Blood Pressure
Time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Heart Rate
Time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Triglycerides and Cholesterol
Time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Homeostatic Model Assessment of Insulin Resistance
Time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Fasting Plasma Glucose, Fasting Plasma Insulin and Glycated Hemoglobin
Time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Alanine Transaminase, Aspartate Transaminase and Gamma Glutamyl Transpeptidase
Time frame: At Baseline and at Day 90, at Day 180 for Cohort 2 and at Day 360 for Cohort 1
Mean Absolute Change and Percent Change of Fatty Liver Controlled Attenuation Parameter Score and Liver Fibrosis Score
Time frame: At Baseline and at Day 90, at Day 180 for Cohort 2 and at Day 360 for Cohort 1
Number of Participants Reported with At least One Treatment Emergent Adverse Event (TEAE)
Time frame: At each visit until Day 180 for Cohort 2 and until Day 360 for Cohort 1
Advance Understanding of Dose/Exposure - Response Relationships
Time frame: At Baseline, at Day 90, Day 180 and at Day 360 for Cohort 1
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APHD-012 and APHD-012P in people with Obese, run by Aphaia Pharma US LLC at 9 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Georgia, Germany, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from Baseline in Percent Weight Change Compared with Placebo (time frame: At Baseline and at each visit until Day 180 for Cohort 2 and Day 360 for Cohort 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.