Brief Summary

This trial is conducted in the United States of America (USA). The purpose of the trial is to investigate the effect and safety of liraglutide 3.0 mg as an adjunct to intensive behaviour therapy for obesity in a non-specialist setting (IBT-CMS: Intensive Behaviour Therapy for obesity in a primary care setting according to Centers for Medicare \& Medicaid Services (CMS) visit schedule).

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

282

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Feb 2017

Geographic Reach

1 country

10 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.4 years study duration

First Submitted

Initial submission to the registry

November 10, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

November 15, 2016

Completed

3 months until next milestone

Study Start

First participant enrolled

February 6, 2017

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2018

Completed

27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 30, 2019

Completed

Last Updated

March 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1.3 years

First QC Date

November 10, 2016

Results QC Date

May 21, 2019

Last Update Submit

February 28, 2020

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (2)

Change in Body Weight (%)
Observed mean change in body weight from baseline (week 0) to week 56 was evaluated for two different observation periods. In-trial observation period: the uninterrupted time interval from the date of randomisation until and including the date of the follow-up visit or date of last contact. On-drug observation period: includes all time intervals in which subjects are considered to be on treatment from the date of first trial product administration to 7 days (or 14 days for AEs) after the final trial product administration, excluding potential off-treatment time intervals triggered by at least 7 consecutive missed doses (or 14 consecutive missed doses for AEs). The test of superiority of liraglutide to placebo for the treatment policy estimand was tested in a hierarchical manner for the two primary and the consequent 7 confirmatory secondary endpoints presented.
Week 0, week 56
Proportion of Subjects Losing at Least 5% of Baseline Body Weight at Week 56
The estimated mean percentage of subjects losing at least 5% of baseline body weight at week 56 is presented. The endpoint was evaluated based on in-trial data and on-drug data.
Week 56

Secondary Outcomes (49)

Proportion of Subjects Losing More Than 10% of Baseline Body Weight at Week 56
Week 56
Proportion of Subjects Losing More Than 15% of Baseline Body Weight at Week 56
Week 56
Proportion of Subjects Losing 4% or More of Baseline Body Weight
Week 16
Change in Waist Circumference (cm)
Week 0, week 56
Change in Short Form-36 (SF-36) v2.0 Acute, Physical Functioning Score
Week 0, week 56
+44 more secondary outcomes

Study Arms (2)

Liraglutide

EXPERIMENTAL

Drug: liraglutideBehavioral: CMS Intensive Behavior Therapy

Placebo

PLACEBO COMPARATOR

Drug: placeboBehavioral: CMS Intensive Behavior Therapy

Interventions

liraglutideDRUG

Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg

Liraglutide

placeboDRUG

Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg

Placebo

CMS Intensive Behavior TherapyBEHAVIORAL

Intensive Behaviour Therapy for obesity

LiraglutidePlacebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
BMI above or equal to 30 kg/m\^2
Male or female, age 18 years or older at the time of signing informed consent

You may not qualify if:

HbA1c (glycosylated haemoglobin) above or equal to 6.5% (at screening visit), or diagnosis of type 1 or type 2 diabetes mellitus
Recent history of cardiovascular disease (myocardial infarction or stroke within the past 6 months), severe congestive heart failure (NYHA class III, IV), or second degree or greater heart block
Personal or family history of Medullary Thyroid Carcinoma (MTC), or Multiple Endocrine Neoplasia type 2 (MEN2)
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice)
Use in past 90 days of medications known to induce significant weight loss (e.g., prescription weight loss medications) or weight gain (e.g., chronic use of oral steroids, second generation antipsychotics)
History of pancreatitis (acute or chronic)
History of major depressive disorder within the past 2 years
Any lifetime history of a suicide attempt
Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic above or equal to 180 mmHg or diastolic above or equal to 110 mmHg)
History of malignancy (except for non-melanoma skin cancer) within the past 5 years

Contact the study team to confirm eligibility.