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

NCT07008456 | Recruiting Phase 2

• 1 other identifier: AP2501
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 6

Brief 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 the placebo beads formulations (APHP 012 and APHD 002) combined with a gel composition in obese subjects with weight related comorbidities.

Conditions

Obese With Comorbidities; Obese Patients (BMI ≥ 30 kg/m²)

Keywords

obesity

Outcome Measures

Primary Outcomes (1)

• Body weight

  Mean percent change in body weight from Baseline at Week 24

  24 weeks

Secondary Outcomes (4)

• Blood Pressure

  24 weeks

• Lipoproteins lipids

  24 weeks

• Fasting Glucose

  24 weeks

• HbA1c

  24 weeks

Study Arms (4)

APHD-012

ACTIVE COMPARATOR

12 g dextrose beads

Drug: APHD-012

APHD-002

ACTIVE COMPARATOR

2 g dextrose beads

Drug: APHD-002

APHP-012

PLACEBO COMPARATOR

12 g placebo beads

Drug: APHP-012

APHP-002

PLACEBO COMPARATOR

2 g placebo beads

Drug: APHP-002

Interventions

APHD-012 DRUG

12 g dextrose beads

APHD-012

APHD-002 DRUG

2 g dextrose beads

APHD-002

APHP-012 DRUG

12 g placebo beads

APHP-012

APHP-002 DRUG

2 g placebo beads

APHP-002

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• \. 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
• 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.
• \. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

You may not qualify if:

• \. 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.
• \. 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
• 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.

Sponsors & Collaborators

• Aphaia Pharma US LLC: lead

Study Sites (6)

LTD "Israeli-Georgian Medical Research Clinic Healthycore"

Tbilisi, K'alak'i T'bilisi, 0112, Georgia

RECRUITING

LTD "New Hospitals"

Tbilisi, K'alak'i T'bilisi, 0114, Georgia

RECRUITING

LTD "Acad. G. Chapidze Emergency Cardiology Center"

Tbilisi, K'alak'i T'bilisi, 0159, Georgia

RECRUITING

LTD "Diacor"

Tbilisi, K'alak'i T'bilisi, 0159, Georgia

RECRUITING

NNLE "Jo Ann University Hospital"

Tbilisi, K'alak'i T'bilisi, 0159, Georgia

RECRUITING

LTD The First Medical Center

Tbilisi, K'alak'i T'bilisi, 0180, Georgia

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Steffen S Bolz, Prof. (Univ. Toronto) Dr. med.

CONTACT

+41/41/78496331; bolz@aphaiapharma.com

Susanne K Grafe, MD

CONTACT

+41/41/78496331; grafe@aphaiapharma.com

Study Design

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

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 6, 2025
• Study Start: September 12, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: September 16, 2025

Record last verified: 2025-09

Locations

GE (6)