Actively Recruiting
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
Led by Aphaia Pharma US LLC · Updated on 2025-09-16
102
Participants Needed
6
Research Sites
41 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official 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 30 kg/m2 with at least one weight-related comorbidity such as hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea (for those over 30 years)
- Stable body weight with less than 5% change in the 3 months before randomization
- History of at least one unsuccessful dietary weight loss attempt
- Fully vaccinated against COVID-19 according to WHO, FDA, or EMA guidelines, or recovered from COVID-19 with at least one vaccination
- Ability to give signed informed consent and comply with study requirements
You will not qualify if you...
- Prior or planned surgical obesity treatment (except liposuction or abdominoplasty performed over 1 year before screening)
- Obesity caused by other endocrine disorders or genetic syndromes
- Planned or recent device-based obesity therapy or device removal within 12 months
- Severe kidney impairment (eGFR less than 30 mL/min/1.73 m2)
- Recent serious cardiovascular events within 60 days before screening
- Classified as NYHA Class III or IV heart failure
- Elevated resting heart rate over 100 bpm at screening
- Significant ECG abnormalities
- Known severe gastric emptying disorders or past bariatric surgeries
- History of pancreatitis, diverticulitis, autoimmune diseases, or significant gallbladder disease
- Liver disease other than non-alcoholic fatty liver disease with abnormal liver enzyme levels
- Thyroid disorders posing safety risks unless stable and controlled
- Family history of certain thyroid cancers
- Nighttime eating habits after 10 p.m. (unless working night shifts)
- History of eating disorders such as bulimia or anorexia nervosa
- Recent severe psychiatric disorders or history of suicide attempt
- Cancer diagnosed within the last 5 years (except certain skin cancers)
- Positive HIV, hepatitis B or C infection
- Unstable glucose-lowering treatments or use of certain diabetes medications recently
- Use of non-herbal Chinese or local medicines with unknown content recently
- Planned surgeries during the trial, except minor procedures
- Known or suspected abuse of alcohol or recreational drugs
- Known allergy to the trial products
- Participation in another clinical trial within 90 days before screening
- Pregnant, breastfeeding, or not using effective contraception if of childbearing potential
- Any condition that may affect safety or compliance as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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.
CONTACT
S
Susanne K Grafe, MD
CONTACT
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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