A Study of Distal Jejunal-release Dextrose in Obese Participants
NCT05385978 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2024-10-16
Summary
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.
Conditions
Interventions
- DRUG
-
APHD-012
Distal jejunal-release dextrose beads (Aphaia technology, AT)
- DRUG
-
APHD-012P
Distal jejunal-release placebo beads
Sponsors & Collaborators
-
Aphaia Pharma US LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-11-01
- Primary Completion
- 2024-11-11
- Completion
- 2024-11-11
- FDA Drug
- Yes
Countries
- Georgia
- Germany
- Puerto Rico
Study Locations
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