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Compares treatment options for Obese With Comorbidities
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
ClinicalTrials.gov ID: NCT07008456
What this study is testing
What is APHD-012?
APHD-012 is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for obese with comorbidities.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Male and female people 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...
- ≥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)...
You likely can't join if
- 1\. Prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed \>1 year prior to screening) 2. Obesity...
- mucosal ablation
- gastric artery embolization
- intragastric balloon
- duodenal-jejunal endoluminal liner. 4. Renal impairment measured as estimated glomerular filtration rate (eGFR) \ 100 bpm) at Screening and Visit 1...
- Alanine aminotransferase (ALT) level \>3.0X Upper limit of normal (ULN) for the reference range
See the full eligibility criteria
- Male and female people 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...
- 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...
- 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...
- mucosal ablation
- gastric artery embolization
- intragastric balloon
- duodenal-jejunal endoluminal liner. 4. Renal impairment measured as estimated glomerular filtration rate (eGFR) \ 100 bpm) at Screening and Visit 1 8. Electrocardiogram (ECG) considered clinic ally significant by the...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Tbilisi, K'alak'i T'bilisi, Georgia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tbilisi, K'alak'i T'bilisi, Georgia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.