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A Study to Examine the Safety, Tolerability and Biological Effects of REGN4461 in Healthy Volunteers

NCT03530514 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2020-03-09

No results posted yet for this study

Summary

The primary objective of the study is to evaluate the safety and tolerability of REGN4461 in healthy participants. The secondary objectives of the study are to:

* Characterize the Pharmacokinetic (PK) profile of single and repeated doses of REGN4461 and evaluate the effects of baseline covariates on PK profile
* Estimate the effects of repeated doses of REGN4461 on body weight over 12 weeks in overweight and obese participants
* Assess the effects of repeated doses of REGN4461 on ad lib energy intake in overweight and obese participants
* Evaluate the effects of single and repeated doses of REGN4461 on soluble forms of lipid-regulating proteins levels over time
* Assess the immunogenicity of single and repeated doses of REGN4461

Conditions

  • Healthy Volunteers

Interventions

DRUG

REGN4461

REGN4461

DRUG

Placebo

Placebo-matching REGN4461

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-04-24
Primary Completion
2020-01-27
Completion
2020-01-27

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03530514 on ClinicalTrials.gov