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NCT04521738 · ClinicalTrials.gov registry record · Phase 1

First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects

A Phase 1 study of Overweight and Healthy Subjects, sponsored by Sanofi.

Completed
Registry status
Phase 1
Development phase
48
Enrollment target
1
Study location

NCT04521738 is a Phase 1 study of Overweight and Healthy Subjects that has completed, run by Sanofi. The registered enrollment target is 48 participants, below the 1,323-participant average among 197 other Overweight trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04521738, a Phase 1 study of Overweight and Healthy Subjects, has completed, sponsored by Sanofi.

COMPLETED
Registry status
Phase 1
Development phase
48 participants
Enrollment target
1
Study location

Study Summary

Primary Objective: To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses Secondary Objectives: To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses To assess the pharmacodynamic effects on glycemic parameters (fasting and postprandial glucose, C-peptide and insulin)

Interventions

  • DRUG placebo
  • DRUG SAR441255

Study Locations (1)

Tennessee

  • Investigational site number 8400001 - Knoxville

Trial Details

FieldValue
Enrollment Target 48 participants
Start Date 2019-04-25
Est. Completion 2019-09-26
Phase Phase 1

Sponsor

Sanofi

713 total trials

What the Registry Record Tells You About NCT04521738

The ClinicalTrials.gov registry entry for NCT04521738 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,323-participant average among 197 other Overweight trials with a reported enrollment target (96% lower). The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Overweight appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.

NCT04521738 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.

Frequently Asked Questions

What is clinical trial NCT04521738 about?

NCT04521738 is a clinical study titled "First-in-human Study to Assess Safety and Tolerability of a Single Subcutaneous Dose of SAR441255 in Lean to Overweight Subjects". Primary Objective: To assess the safety and tolerability of SAR441255 after ascending single subcutaneous (SC) doses Secondary Objectives: To assess the pharmacokinetic parameters of SAR441255 in plasma after ascending single SC doses To assess the pharmacodynamic effects on glycemic parameters ...

What is the current status of trial NCT04521738?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 48 participants. The study started on 2019-04-25. Estimated completion is 2019-09-26.

What conditions does trial NCT04521738 study?

This clinical trial studies the following conditions: Overweight, Healthy Subjects.

What interventions are being tested in trial NCT04521738?

The interventions under investigation include: placebo (DRUG), SAR441255 (DRUG).

Who is sponsoring clinical trial NCT04521738?

This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04521738 being conducted?

This trial has 1 study location across Tennessee. 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 Editorial

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, or report a data error.