Obesity and Pre-diabetes-Effect of liraglutide on body weight in non-diabetic obese subjects or overweight subjects with comorbidities A randomised, double-blind, placebo controlled, parallel group, multi-centre, multinational trial with stratification of subject to either 56 or 160 weeks of treatment based on pre-diabetes status at randomisation

Study ID
STU 042011-123

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other

Contact
Luisa Morton
214648973379733
luisa.morton@utsouthwestern.edu

Principal Investigator
Chanhaeng Rhee

Summary

This is a randomized, double-blind, placebo controlled, parallel group, multi-centre, multinational
trial in non-diabetic obese subjects and overweight subjects with co-morbidities. Subjects will be
randomized in a 2:1 manner to receive either 3.0 mg liraglutide or liraglutide placebo, and based on
body mass index (BMI [kg/m2]) and pre-diabetes status at randomization subjects will be stratified
to either 56 or 160 weeks of treatment (160 week treatment will only applicable to subjects with
pre-diabetes at screening). Treatment will be stratified by body mass index (BMI [kg/m2]) (BMI ≥
30 kg/m2, or BMI and amp;lt; 30 kg/m2) and pre-diabetes status at baseline . Treatment allocation for subjects with pre-diabetes will be double-blind for the first 56 weeks (Novo Nordisk, Investigator, and subject blinded), after which time point sponsor is un-blinded (Investigator and subject remain blinded to treatment allocation).

A subject will be classified as having pre-diabetes if falling within the following categories of
increased risk for diabetes: Fasting plasma glucose 100 mg/dL ( 5.6 mmol/L) to 125 mg/dL (6.9
mmol/L) (IFG), 2-hour post-challenge oral glucose tolerance test (OGTT) glucose 140 mg/dL (7.8 mmol/L) to 199 mg/dL (11.0 mmol/L) (IGT), or HbA1c 5.7-6.4% both inclusive.

The maximum overall duration of the main part of the trial from screening to follow-up will be 72
weeks including the 12 week re-randomised treatment period. For subjects enrolled in the delayed onset-
of-type-2-diabetes part of the trial the maximum total duration of the trial will be 174 weeks.

Participant Eligibility

1. Informed consent obtained before any trial-related activities (Trial related activities are any
procedure that would not have been performed during the normal management of the subject)
2. Body Mass Index (BMI) ≥ 30.0 kg/m2 or ≥ 27 kg/m2 with presence of co-morbidities of treated
or untreated dyslipidemia and/or hypertension. (Untreated dyslipidemia is defined as LDL ≥ 160
mg/dL, or Triglycerides ≥ 150 mg/dL, or HDL < 40 mg/dL for male and < 50 mg/dL for
female, untreated hypertension is defined as Systolic Blood Pressure ≥ 140 or Diastolic
Blood Pressure ≥ 90 mmHg
3. Stable body weight (less than 5 kg self-reported change during the previous 3 months)
4. Preceding failed dietary effort
5. Age ≥ 18 years

Stratification criteria
To be eligible for stratification to the delayed-onset-of-type-2-diabetes part of the trial, subjects
must comply with the following:
• Fasting Plasma Glucose (FPG) ≥ 100 mg/dL (5.6 mmol/L) and ≤ 125 mg/dL (6.9 mmol/L) At Screening visit 2, and/or
• 2 hr post-challenge oral glucose tolerance test (OGTT) plasma glucose ≥ 140 mg/dL (7.8 mmol/L) and ≤ 199 mg/ dL (11.0
mmol/L) at Screening visit 2, and/or
• Hemoglobin A1c (HbA1c) 5.7-6.4% both inclusive, at Screening visit 1
Subjects will furthermore be stratified according to BMI (≥ 30 kg/m2 or < 30 kg/m2).