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NCT04838639 · ClinicalTrials.gov registry record · Phase 1
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects
A Phase 1 study of Obesity, sponsored by Otsuka Pharmaceutical Factory.
- Completed
- Registry status
- Phase 1
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT04838639: Completed Phase 1 study of Obesity, sponsored by Otsuka Pharmaceutical Factory.
NCT04838639 is a Phase 1 study of Obesity that has completed, run by Otsuka Pharmaceutical Factory. The registered enrollment target is 84 participants, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04838639, a Phase 1 study of Obesity, has completed, sponsored by Otsuka Pharmaceutical Factory.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects.
Primary Outcome
To assess the safety and tolerability of single and multiple ascending oral doses of NO-13065 in healthy, overweight, and obese adult subjects.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG NO-13065
Study Locations (1)
Nebraska
- Celerion - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2021-06-14 |
| Est. Completion | 2022-03-31 |
| Phase | Phase 1 |
What the finished NCT04838639 record still lists
NCT04838639 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Obesity appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04838639 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT04838639 about?
NCT04838639 is a clinical study titled "Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of NO-13065 in Healthy and Obese Adult Subjects". This clinical trial is the first-in-human study of NO-13065. The purpose of this phase 1 study is to assess the safety and tolerability of single and multiple ascending oral doses and food effect of NO-13065 in healthy and obese adult subjects.
What is the current status of trial NCT04838639?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 84 participants. The study started on 2021-06-14. Estimated completion is 2022-03-31.
What conditions does trial NCT04838639 study?
This clinical trial studies the following conditions: Obesity.
What interventions are being tested in trial NCT04838639?
The interventions under investigation include: Placebo (DRUG), NO-13065 (DRUG).
Who is sponsoring clinical trial NCT04838639?
This trial is sponsored by Otsuka Pharmaceutical Factory, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04838639 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Obesity
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04838639's enrollment target sits among peer trials
84 534th of 1053 higher than 516 of 1,053 other Obesity trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Obesity trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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