🏛️ Verified NIH Record • Updated 2024-10-14
A Study of Distal Jejunal-release Dextrose in Obese Participants (NCT05385978)
A Phase II, Randomized, Double-blind, Placebo-controlled, Parallel-group Proof-of-concept Study to Evaluate Efficacy and Safety of Distal Jejunal-release Dextrose (Aphaia Technology, AT) in Obese Subjects
🔵 Active, Not Recruiting Phase2 💊 Investigational Drug / Biologic Sponsor: Aphaia Pharma US LLC
🩺 Plain-English Summary (8th-Grade Level)
The primary purpose of the study is to evaluate the efficacy and safety of APHD-012 (distal jejunal-release dextrose \[Aphaia technology, AT\]) in obese participants.
Who can join: Review the eligibility criteria below.
Location: LTD "Israeli-Georgian Medical Research Clinic Healthycore" — Tbilisi
Age range: 18 Years to 70 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (9 Sites)
- LTD "Israeli-Georgian Medical Research Clinic Healthycore" — Tbilisi,
- LTD "Acad. G. Chapidze Emergency Cardiology Center" — Tbilisi,
- LTD "Diacor" — Tbilisi,
- LTD "National Institute of Endocrinology" — Tbilisi,
- LTD "Tbilisi Heart Center" — Tbilisi,
- Universitätsklinikum Schleswig-Holstein — Lübeck,
- Universitätsklinikum Ruppin-Brandenburg — Neuruppin,
- GCM Medilcal Group — San Juan,
- FDI Clinical Research — San Juan,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- A Clinical Trial to Investigate the Safety and Efficacy of MB-1 on Metabolic Health in Overweight and Obese Adults — London, Ontario
- Dynamo: a Tailored Lifestyle Promotion Intervention Among Pediatric Patients With Cardiometabolic Risk Factors — Montreal, Quebec
Explore by condition: All Obese clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.