NCT02692040

Study of the Gut Hormone Analogue G3215 in Adult Subjects

A Randomised, Placebo Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the Gut Hormone Analogue G3215 in Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Imperial College London · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

A randomised, placebo controlled Phase I study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of G3215 in adult subjects.

Detailed description

Objectives: Primary Objective * To investigate the safety and tolerability of single doses of G3215 in overweight but otherwise healthy male subjects. * To investigate the safety and tolerability of multiple doses of G3215 in overweight male subjects with mild stable Type 2 diabetes or prediabetes. Secondary Objectives • To assess the pharmacokinetic (PK) profile of single and multiple ascending doses of G3215 in overweight but otherwise healthy male subjects or overweight / obese male subjects with mild stable Type 2 diabetes or prediabetes. Exploratory Objective • To investigate the effects of multiple doses of G3215 on food consumption, body weight, enteropancreatic hormone changes and glucose tolerance in overweight male subjects with mild Type 2 diabetes or prediabetes.

Conditions

• Diabetes Mellitus
• Obesity

Interventions

Type	Name	Description
DRUG	G3215	Gut hormone analogue
DRUG	Placebo	0.9% saline

Timeline

• Start date: 2015-01-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2016-02-25
• Last updated: 2020-12-23
• Results posted: 2020-12-23

Locations

1 site across 1 country: United Kingdom