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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.

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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.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG NO-13065

Study Locations (1)

Nebraska

  • Celerion - Lincoln

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2021-06-14
Est. Completion 2022-03-31
Phase Phase 1

Sponsor

Otsuka Pharmaceutical Factory

2 total trials

What the Registry Record Tells You About NCT04838639

The ClinicalTrials.gov registry entry for NCT04838639 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 819-participant average among 1,053 other Obesity trials with a reported enrollment target (90% lower). The listed sponsor is Otsuka Pharmaceutical Factory, which has 2 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.