NCT03673111

Study of the Gut Hormone Analogue Y14 in Adult Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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 and glucose tolerance in overweight/obese male subjects with normal glucose tolerance, Type 2 diabetes or prediabetes.

Conditions

• Diabetes Mellitus
• Obesity

Interventions

Type	Name	Description
DRUG	Y14	Gut hormone analogue
DRUG	Placebo	0.9% saline

Timeline

• Start date: 2017-04-10
• Primary completion: 2019-02-13
• Completion: 2019-02-13
• First posted: 2018-09-17
• Last updated: 2025-03-18
• Results posted: 2025-03-18

Locations

1 site across 1 country: United Kingdom