TAK-094 First in Human Study

• Research type

  Research Study

• Full title

  A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Rising Dose Study to Evaluate the Safety, Tolerability and Pharmcokinetics of Escalating Single or Multiple Subcutaneous Doses of TAK-094 in Healthy Lean and Overweight/Obese Otherwise Healthy Subjects

• IRAS ID

  178100

• Contact name

  Jim Bush

• Contact email

  jim.bush@covance.com

• Sponsor organisation

  Takeda Development Cantre Europe

• Eudract number

  2015-000888-13

• Duration of Study in the UK

  0 years, 9 months, 0 days

• Research summary

  Takeda is developing TAK-094, a glucagon-like peptide-1 receptor (GLP-1R) and glucose-dependent insulinotrophic polypeptide receptor (GIPR) co-agonist, for weight loss when used in combination with a reduced calorie diet in obese and overweight people and for blood sugar control in people with type 2 diabetes mellitus. The purpose of this study is to assess the safety, tolerability and pharmacokinetics in healthy lean and otherwise healthy overweight/obese subjects and the effect on appetite control, weight loss and insulin response in otherwise healthy overweight/obese subjects of subcutaneous TAK-094 administration.

  This is a randomised, double-blind, placebo-controlled, first in human study in two Parts in approximately 120 male and female subjects. Part 1 will investigate single ascending doses in 8 cohorts of healthy lean subjects with one cohort of otherwise healthy overweight/obese subjects and Part 2 will investigate multiple ascending doses in 4 cohorts of otherwise healthy overweight/obese subjects.

  In Part 1 each cohort will include 6 subjects treated with TAK-094 and 2 subjects treated with placebo. Sentinel dosing will occur in 2 subjects in the first cohort only of Part 1. Subjects will be confined to the Research Unit from the day before dosing (Day - ) until 2 days after dosing (Day 3).

  In Part 2 each cohort will include 9 subjects treated with TAK-094 and 3 subjects treated with placebo. Subjects will be dosed once daily for 7 days and will be confined to the Research Unit from 2 days before dosing (Day -2) until 1 day after the final administration of study drug (Day 8).

• REC name

  North East - York Research Ethics Committee

• REC reference

  15/NE/0241

• Date of REC Opinion

  29 Jul 2015

• REC opinion

  Further Information Favourable Opinion