Obese With ComorbiditiesPhase 2NCT07008456
A Study to Investigate the Efficacy and Safety of Two Different Doses of Twice Daily Distal Jejunal-release Dextrose Beads Formulations Combined With a Gel Composition Compared to Placebos in Obese Subjects With Weight Related Comorbidities
A Phase 2 study testing APHD-012, APHD-002 and APHP-012 in people with Obese With Comorbidities and Obese Patients (BMI ≥ 30 kg/m²), run by Aphaia Pharma US LLC at 6 sites in Georgia.
Trial summary
The goal of this randomized, double-blind, placebo-controlled, phase IIa study is to demonstrate superiority on body weight reduction of two different doses of twice daily distal jejunal-release dextrose beads formulations (APHD 012 and APHD 002) combined with a gel composition, compared with two different doses of… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Obese With Comorbidities, Obese Patients (BMI ≥ 30 kg/m²)
- What is being tested?
- APHD-012, APHD-002 and APHP-012
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 6 sitesGeorgia
- Study dates
- 12 Sep 2025to Jul 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female subjects between an age of 18 (or the legal age of consent in the jurisdiction where the study is conducted) and 75 at the time of signing Informed Consent Form (ICF).
- 2. Body Mass Index (BMI) of
- ≥30 kg/m2
- ≥27 kg/m2 and <30 kg/m2 with at least 1 of the following weight-related comorbidities
- hypertension: on blood-pressure (BP)-lowering medication or having systolic BP (SBP) ≥140 mmHg or diastolic BP (DBP) ≥90 mmHg at Screening
- dyslipidaemia: on lipid-lowering medication or having low-density lipoprotein (LDL) ≥160 mg/dL (4.1 mmol/L) or triglycerides ≥150 mg/dL (1.7 mmol/L), or high-density lipoprotein (HDL) <40 mg/dL (1.0 mmol/L) for men or HDL <50 mg/dL (1.3 mmol/L) for women at Screening
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- cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association [NYHA] Functional Classification Class I-II heart failure.)
- obstructive sleep apnoea (only in participants >30 years of age) 3. Stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss) 4. History of at least one self-reported unsuccessful dietary effort to lose body weight 5. Fully vaccinated against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) during Coronavirus Disease 2019 (COVID-19) pandemic. Full Vaccination means having received all recommended doses of a COVID-19 vaccine listed by either of World Health Organization (WHO)-Emergency Use Listing (WHO-EUL), Food and Drug Administration (FDA) or European Medicines Agency (EMA) or a mix and match series composed of any heterologous combination of WHO-EUL/FDA/EMA-approved or authorized COVID-19 vaccines. Alternatively, a proven recovery from a COVID-19 infection in combination with at least one vaccination with a WHO, FDA, EMA listed vaccine qualifies as a full vaccination. The vaccination program must have been completed at least two weeks prior ICF signed. For the avoidance of doubt, the vaccination scheme received shall be in compliance with the current rules defined by the relevant health authorities in the US or Europe.
- 6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Who cannot join
- 1. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening) 2. Obesity induced by other endocrinologic disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome) 3. Plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 12 months prior to screening including but not limited to
- mucosal ablation
- gastric artery embolization
- intragastric balloon
- duodenal-jejunal endoluminal liner. 4. Renal impairment measured as estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2 during screening.
- 5. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 60 days prior to screening 6. Subject presently classified as being in New York Heart Association (NYHA) Class III and IV 7. Elevated resting pulse rate (>100 bpm) at Screening and Visit 1 8. Electrocardiogram (ECG) considered clinic ally significant by the Investigator at Screening 9. Known clinically significant gastric emptying abnormalities (for example, severe gastroparesis or gastric outlet obstruction), past gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, Lap-Band®), or chronic intake of drugs directly affecting gastrointestinal (GI) motility 10. History or presence of acute or chronic pancreatitis. 11. History or presence of acute or chronic diverticulitis or diverticulosis. 12. History or presence of a clinically significant active autoimmune abnormality (for example, lupus or rheumatoid arthritis) 13. History or presence of clinically significant gallbladder disease 14. Signs and symptoms of any other liver disease other than non-alcoholic fatty liver disease, or any of the following as determined during screening
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- Alanine aminotransferase (ALT) level >3.0X Upper limit of normal (ULN) for the reference range
- Alkaline phosphatase (ALP) level >1.5X ULN for the reference range, or
- Total Bilirubin >1.5X ULN for the reference range (except for cases of known Gilbert's Syndrome) 15. Evidence of hypothyroidism or hyperthyroidism based on clinical evaluation and/or an abnormal thyroid-stimulating hormone that, in the opinion of the Investigator, would pose a risk to patient safety. Subjects on a stable dose of thyroid replacement therapy for at least the prior 3 months before Visit 1 who are clinically euthyroid and who are anticipated to remain on this dose throughout the trial period may be eligible if they meet the other criteria 16. Known self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma 17. Eating habits consisting of eating relevant amounts of food throughout the night (after 10 p.m.; except if working on night shifts) 18. History or presence of bulimia or anorexia nervosa 19. History or presence of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder (for example, schizophrenia, bipolar disorder, or other serious mood or anxiety disorder) within the last 2 years.
- 20. Lifetime history of suicide attempt 21. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed 22. Evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at Screening 23. Evidence of hepatitis B and/or positive hepatitis B surface antigen. 24. Hepatitis C as defined by presence of positive hepatitis C antibodies. 25. Unstable treatment with glucose-lowering agent(s) within 90 days before Visit 1 26. Treatment with incretin mono- or dual receptor agonists (e.g., Glucagon-like peptide 1 (GLP-1) or GLP-1/ Glucose-dependent insulinotropic polypeptide (GIP)) within 180 days prior to screening and planned during the present study 27. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening 28. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator 29. Known or suspected abuse of alcohol or recreational drugs 30. Illicit drug abuse (marihuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines) 31. Known or suspected hypersensitivity to trial product(s) or related products 32. Participation in another clinical trial within 90 days before screening 33. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method 34. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Georgia6 sites, 6 recruiting
- Recruiting
LTD "Israeli-Georgian Medical Research Clinic Healthycore"
Tbilisi, K'alak'i T'bilisi, 0112
Miranda Baratashvili, MD Prof., +995 32 243 33 43, baratashvilimiranda@gmail.com
- Recruiting
LTD "New Hospitals"
Tbilisi, K'alak'i T'bilisi, 0114
Lia Katcharava, MD Prof., +995 32 219 01 90, likakatcharava@yahoo.com
- Recruiting
LTD "Acad. G. Chapidze Emergency Cardiology Center"
Tbilisi, K'alak'i T'bilisi, 0159
Medea Amashukeli, MD Prof., +995 32 240 23 01
- Recruiting
LTD "Diacor"
Tbilisi, K'alak'i T'bilisi, 0159
Lali Nikoleishvili, MD Prof., +995 599 900022, diabprevention@gmail.com
- Recruiting
NNLE "Jo Ann University Hospital"
Tbilisi, K'alak'i T'bilisi, 0159
Nino Meladze, MD Prof., +995 32 222 22 11, ninomeladze@yahoo.com
- Recruiting
LTD The First Medical Center
Tbilisi, K'alak'i T'bilisi, 0180
Maia Kobulia, MD Prof., +995 32 269 86 05, maikobulia@yahoo.com
About this study
Official title: A Phase II Study to Investigate the Efficacy and Safety of Two Different Doses of Twice Daily Distal Jejunal-release Dextrose Beads Formulations (APHD 012 and APHD 002) Combined With a Gel Composition, Compared With Two Different Doses of the Placebo Beads Formulations (APHP 012 and APHP 002) Combined With a Gel Composition in Obese Subjects With Weight Related Comorbidities
The goal of this randomized, double-blind, placebo-controlled, phase IIa study is to demonstrate superiority on body weight reduction of two different doses of twice daily distal jejunal-release dextrose beads formulations (APHD 012 and APHD 002) combined with a gel composition, compared with two different doses of the placebo beads formulations (APHP 012 and APHD 002) combined with a gel composition in obese subjects with weight related comorbidities.
- Being tested
- APHD-012, APHD-002, APHP-012, APHP-002
- Keywords
- obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APHD-012Drug
12 g dextrose beads
APHD-002Drug
2 g dextrose beads
APHP-012Drug
12 g placebo beads
APHP-002Drug
2 g placebo beads
| Study group | Role | What they receive |
|---|---|---|
| APHD-012 | Active comparator | 12 g dextrose beads Receives: Drug: APHD-012 |
| APHD-002 | Active comparator | 2 g dextrose beads Receives: Drug: APHD-002 |
| APHP-012 | Placebo comparator | 12 g placebo beads Receives: Drug: APHP-012 |
| APHP-002 | Placebo comparator | 2 g placebo beads Receives: Drug: APHP-002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Mean percent change in body weight from Baseline at Week 24
Measured: 24 weeks
Secondary outcomes (4)
Blood Pressure
Change in blood pressure (systolic and diastolic blood pressure) from Baseline at Week 24
Measured: 24 weeks
Lipoproteins lipids
Change in lipoprotein lipids (Low-density lipoprotein cholesterol (LDL-C) and High-density lipoprotein cholesterol (HDL-C) from Baseline at Week 24
Measured: 24 weeks
Fasting Glucose
Change in fasting glucose from Baseline at Week 24
Measured: 24 weeks
HbA1c
Change in HbA1c (in subjects with Type 2 Diabetes Mellitus) at Week 24
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start12 Sep 2025
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese With ComorbiditiesStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 102 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
- NCT07008456
- Sponsor's protocol ID
- AP2501
- Status last verified
- Sep 2025
- First submitted
- 29 May 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Investigate the Efficacy and Safety of Two Different Doses of Twice Daily Distal Jejunal-release Dextrose Beads Formulations (APHD 012 and APHD 002) Combined With a Gel Composition, Compared With Two Different Doses of the Placebo Beads Formulations (APHP 012 and APHP 002) Combined With a Gel Composition in Obese Subjects With Weight Related Comorbidities
- ClinicalTrials.gov ID
- NCT07008456
- Acronym / sponsor ID
- AP2501
- Keywords
- obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Aphaia Pharma US LLCIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Jun 2025 (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 goal of this randomized, double-blind, placebo-controlled, phase IIa study is to demonstrate superiority on body weight reduction of two different doses of twice daily distal jejunal-release dextrose beads formulations (APHD 012 and APHD 002) combined with a gel composition, compared with two different doses of the placebo beads formulations (APHP 012 and APHD 002) combined with a gel composition in obese subjects with weight related comorbidities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| APHD-012 | Active comparator | Drug: APHD-01212 g dextrose beads |
| APHD-002 | Active comparator | Drug: APHD-0022 g dextrose beads |
| APHP-012 | Placebo comparator | Drug: APHP-01212 g placebo beads |
| APHP-002 | Placebo comparator | Drug: APHP-0022 g placebo beads |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female subjects between an age of 18 (or the legal age of consent in the jurisdiction where the study is conducted) and 75 at the time of signing Informed Consent Form (ICF).
- 2. Body Mass Index (BMI) of
- 6. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
Key exclusion criteria (10 listed)
- 1. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening) 2. Obesity induced by other endocrinologic disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader-Willi Syndrome) 3. Plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 12 months prior to screening including but not limited to
- 5. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 60 days prior to screening 6. Subject presently classified as being in New York Heart Association (NYHA) Class III and IV 7. Elevated resting pulse rate (>100 bpm) at Screening and Visit 1 8. Electrocardiogram (ECG) considered clinic ally significant by the Investigator at Screening 9. Known clinically significant gastric emptying abnormalities (for example, severe gastroparesis or gastric outlet obstruction), past gastric bypass (bariatric) surgery or restrictive bariatric surgery (for example, Lap-Band®), or chronic intake of drugs directly affecting gastrointestinal (GI) motility 10. History or presence of acute or chronic pancreatitis. 11. History or presence of acute or chronic diverticulitis or diverticulosis. 12. History or presence of a clinically significant active autoimmune abnormality (for example, lupus or rheumatoid arthritis) 13. History or presence of clinically significant gallbladder disease 14. Signs and symptoms of any other liver disease other than non-alcoholic fatty liver disease, or any of the following as determined during screening
- 20. Lifetime history of suicide attempt 21. History of malignant neoplasms within the past 5 years prior to screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed 22. Evidence of human immunodeficiency virus (HIV) and/or positive HIV antibodies historically or at Screening 23. Evidence of hepatitis B and/or positive hepatitis B surface antigen. 24. Hepatitis C as defined by presence of positive hepatitis C antibodies. 25. Unstable treatment with glucose-lowering agent(s) within 90 days before Visit 1 26. Treatment with incretin mono- or dual receptor agonists (e.g., Glucagon-like peptide 1 (GLP-1) or GLP-1/ Glucose-dependent insulinotropic polypeptide (GIP)) within 180 days prior to screening and planned during the present study 27. Use of non-herbal Chinese medicine or other non-herbal local medicine with unknown/unspecified content within 90 days before screening 28. Surgery scheduled for the duration of the trial, except for minor surgical procedures, in the opinion of the investigator 29. Known or suspected abuse of alcohol or recreational drugs 30. Illicit drug abuse (marihuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines) 31. Known or suspected hypersensitivity to trial product(s) or related products 32. Participation in another clinical trial within 90 days before screening 33. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method 34. Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardize the subject's safety or compliance with the protocol
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-01212 g dextrose beads | Drug | APHD-012 |
| APHD-0022 g dextrose beads | Drug | APHD-002 |
| APHP-01212 g placebo beads | Drug | APHP-012 |
| APHP-0022 g placebo beads | Drug | APHP-002 |
Primary outcome
Body weight
Time frame: 24 weeks
Mean percent change in body weight from Baseline at Week 24
4 secondary outcomes
Blood Pressure
Time frame: 24 weeks
Lipoproteins lipids
Time frame: 24 weeks
Fasting Glucose
Time frame: 24 weeks
HbA1c
Time frame: 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Undecided
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing APHD-012, APHD-002 and APHP-012 in people with Obese With Comorbidities and Obese Patients (BMI ≥ 30 kg/m²), run by Aphaia Pharma US LLC at 6 sites in Georgia.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Georgia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steffen S Bolz, Prof. (Univ. Toronto) Dr. med. (+41/41/78496331, bolz@aphaiapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body weight (time frame: 24 weeks). 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 Sep 2025.