Actively Recruiting
A Phase II 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 With Placebo in Obese Adults With Weight Related Comorbidities
Led by Aphaia Pharma US LLC · Updated on 2025-09-16
102
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of two different doses of distal jejunal-release dextrose beads combined with a gel composition on body weight reduction in obese adults with weight-related health issues. This phase IIa randomized, double-blind, placebo-controlled study aims to show whether these treatments provide better weight loss compared to placebo beads combined with the same gel composition. Participants will be assigned to one of four groups receiving either 12 g or 2 g of the active dextrose beads (APHD-012 or APHD-002) or matching placebo beads (APHP-012 or APHP-002). These treatments are taken twice daily. The study compares the effects of these doses over a 24-week period. During the study, participants will undergo assessments including body weight, blood pressure, blood lipid levels, fasting glucose, and HbA1c measurements at 24 weeks. Researchers will monitor safety and adherence throughout. The total participation lasts at least 24 weeks, during which weight and metabolic health are closely evaluated.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults aged 18 to 75 years
- Body mass index (BMI) of 30 kg/m2 or higher
- BMI between 27 and less than 30 kg/m2 with at least one weight-related comorbidity such as hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea (if over 30 years old)
- Stable body weight within 5% gain or loss for 3 months before randomization
- History of at least one unsuccessful dietary effort to lose weight
- Fully vaccinated against COVID-19 or recovered from infection with at least one vaccination
- Capable of giving signed informed consent and complying with study requirements
You will not qualify if you...
- Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty more than 1 year before screening)
- Obesity caused by endocrine disorders or genetic/syndromic forms
- Planned or recent (within 12 months) endoscopic or device-based obesity treatments
- Severe kidney impairment (eGFR <30 mL/min/1.73 m2)
- Recent (within 60 days) serious cardiovascular events such as heart attack or stroke
- New York Heart Association Class III or IV heart failure
- Elevated resting pulse rate over 100 bpm at screening
- Significant abnormal ECG findings
- Known severe gastric emptying problems or previous bariatric surgery
- History or presence of acute or chronic pancreatitis, diverticulitis, autoimmune diseases, or significant gallbladder disease
- Abnormal liver tests exceeding defined limits
- Thyroid disorders posing safety risks unless stable and well-controlled
- Family history of certain thyroid cancers
- Night eating habits after 10 p.m. (unless working night shifts)
- Eating disorders like bulimia or anorexia nervosa
- Severe psychiatric disorders or recent major depressive episodes
- Lifetime history of suicide attempt
- Cancer within past 5 years (except certain skin cancers)
- HIV or hepatitis B or C infection
- Unstable glucose-lowering treatments
- Recent use of certain incretin receptor agonists
- Recent use of non-herbal Chinese or local medicines with unknown content
- Scheduled surgeries during trial except minor procedures
- Alcohol or drug abuse
- Known allergies to study products
- Participation in another clinical trial within 90 days
- Pregnancy, breastfeeding, or not using effective contraception if of childbearing potential
- Any other condition that might risk safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive one of two doses of distal jejunal-release dextrose beads formulations or placebos twice daily to evaluate efficacy and safety for weight-related comorbidities.
Regular visits throughout the 24-week treatment period
Trial Site Locations
Total: 6 locations
1
LTD "Israeli-Georgian Medical Research Clinic Healthycore"
Tbilisi, K'alak'i T'bilisi, Georgia, 0112
Actively Recruiting
2
LTD "New Hospitals"
Tbilisi, K'alak'i T'bilisi, Georgia, 0114
Actively Recruiting
3
LTD "Acad. G. Chapidze Emergency Cardiology Center"
Tbilisi, K'alak'i T'bilisi, Georgia, 0159
Actively Recruiting
4
LTD "Diacor"
Tbilisi, K'alak'i T'bilisi, Georgia, 0159
Actively Recruiting
5
NNLE "Jo Ann University Hospital"
Tbilisi, K'alak'i T'bilisi, Georgia, 0159
Actively Recruiting
6
LTD The First Medical Center
Tbilisi, K'alak'i T'bilisi, Georgia, 0180
Actively Recruiting
Research Team
S
Steffen S Bolz, Prof. (Univ. Toronto) Dr. med.
S
Susanne K Grafe, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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