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Study of the Gut Hormone Analogue Y14 in Adult Subjects

Obesity Clinical Trial

Official title:
A Randomised, Placebo Controlled First in Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Y14 in Adult Subjects

Clinical Trial Summary

A randomised, placebo controlled Phase I study to investigate investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of Y14 in adult subjects.

Clinical Trial Description

Objectives:

Primary Objective

- To investigate the safety and tolerability of single doses of Y14 in overweight/obese but otherwise healthy male subjects.

- To investigate the safety and tolerability of multiple doses of Y14 in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

Secondary Objectives

- To assess the pharmacokinetic (PK) profile of single doses of Y14 in overweight/obese but otherwise healthy male subjects.

- To assess the PK profile of multiple ascending doses of Y14 in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

Exploratory Objective

- To investigate the effects of multiple doses of Y14 on food consumption, body weight, enteropancreatic hormone changes and glucose tolerance in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03673111
Study type Interventional
Source Imperial College London
Contact
Status Completed
Phase Phase 1
Start date May 10, 2017
Completion date December 24, 2018
View Details
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