Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT03048578
Collaborator
Novo Nordisk A/S (Industry)
132
1
2
45.3
2.9

Study Details

Study Description

Brief Summary

This is a randomized, double-blinded, placebo-controlled trial of liraglutide versus placebo over a follow-up period of 12 months in patients at least 18 months following Roux-en-Y gastric bypass (RYGB) who are experiencing weight regain. This study will assess the efficacy of liraglutide in improving cardiometabolic risk profile (as indicated by serum lipids, HbA1c, and waist circumference) and quality of life (as assessed by PHQ-9 (Patient Health Questionnaire), versus placebo in patients at least 18 months following RYGB who are experiencing weight regain as well as the safety of liraglutide in this patient population.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The specific aims of this study are to:
  • To evaluate the effects of liraglutide on body weight loss in patients who are experiencing weight regain following RYGB.

  • To evaluate the effects of liraglutide on cardiometabolic risk and quality of life in patients who are experiencing weight regain following RYGB.

  • To evaluate the safety of liraglutide in post-RYGB subjects.

  • To evaluate the changes in obesity-related comorbid conditions in patients who are experiencing weight regain following RYGB.

Study Design

Study Type:
Interventional
Actual Enrollment :
132 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomization will be 2:1 (drug:placebo) with stratification by gender and percent post-operative TBWL (25%, 25 - 49.9%).Randomization will be 2:1 (drug:placebo) with stratification by gender and percent post-operative TBWL (25%, 25 - 49.9%).
Masking:
Double (Participant, Care Provider)
Primary Purpose:
Treatment
Official Title:
Clinical Efficacy and Safety of Using 3.0mg Liraglutide to Treat Weight Regain After Roux-en-Y Gastric Bypass Surgery
Actual Study Start Date :
May 22, 2017
Actual Primary Completion Date :
Mar 2, 2021
Actual Study Completion Date :
Mar 2, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: Saxenda

Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day

Drug: Saxenda
Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day
Other Names:
  • Victoza
  • Placebo Comparator: Placebo

    Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day

    Drug: Placebo
    Subcutaneous Saline Solution

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test [12 Months]

      CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ≥18 months status-post RYGB

    • BMI 27 kg/m2 or greater in the presence of at least one weight-related comorbid condition

    • BMI 30 kg/m2 or greater

    • Regain of ≥10% of maximum TBWL post-RYGB

    • Ability to provide informed consent before any trial-related activities

    • Express willingness to follow protocol requirements

    Exclusion Criteria:
    • Pregnancy at time of enrollment

    • Intention of becoming pregnant or breast feeding in the next 12 months

    • Females of childbearing potential who are not using adequate contraceptive methods

    • Presence of acute psychiatric problems or immaturity which would compromise cooperation with the study protocol

    • Presence of biliary disease

    • Known or suspected allergy to liraglutide or any product components

    • Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2

    • History of pancreatitis

    • History of alcoholism

    • History of Type 1 DM (Diabetes Mellitus)

    • History of previous bariatric surgery other than RYGB except h/o LAGB and band removal.

    • 10 years status-post RYGB

    • < 25% TBWL at post-RYGB weight nadir

    • 50% post-operative TBWL at time of screening

    • Simultaneous use of any weight loss medications

    • Use of insulin at the time of enrollment

    • Current use of any GLP-1 agonist medication

    • History of taking any GLP-1 agonist medication

    • Participation in another ongoing clinical study

    • Conditions that, in the opinion of the principal investigator, may jeopardize the patient's well-being and/or the soundness of this clinical study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University Medical Center New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • Novo Nordisk A/S

    Investigators

    • Principal Investigator: Holly Lofton, MD, NYU Langone Health

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT03048578
    Other Study ID Numbers:
    • 16-01527
    First Posted:
    Feb 9, 2017
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Feb 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by NYU Langone Health
    Additional relevant MeSH terms:

    Study Results

    Participant Flow

    Recruitment Details
    Pre-assignment Detail
    Arm/Group Title Saxenda Placebo
    Arm/Group Description Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Placebo: Subcutaneous Saline Solution
    Period Title: Overall Study
    STARTED 89 43
    COMPLETED 58 23
    NOT COMPLETED 31 20

    Baseline Characteristics

    Arm/Group Title Saxenda Placebo Total
    Arm/Group Description Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Placebo: Subcutaneous Saline Solution Total of all reporting groups
    Overall Participants 58 23 81
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    49.4
    (8.9)
    50.4
    (11.9)
    49.7
    (9.8)
    Sex: Female, Male (Count of Participants)
    Female
    49
    84.5%
    20
    87%
    69
    85.2%
    Male
    9
    15.5%
    3
    13%
    12
    14.8%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    8
    13.8%
    3
    13%
    11
    13.6%
    Not Hispanic or Latino
    50
    86.2%
    20
    87%
    70
    86.4%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    0
    0%
    0
    0%
    0
    0%
    Asian
    1
    1.7%
    0
    0%
    1
    1.2%
    Native Hawaiian or Other Pacific Islander
    1
    1.7%
    2
    8.7%
    3
    3.7%
    Black or African American
    15
    25.9%
    8
    34.8%
    23
    28.4%
    White
    32
    55.2%
    13
    56.5%
    45
    55.6%
    More than one race
    1
    1.7%
    0
    0%
    1
    1.2%
    Unknown or Not Reported
    8
    13.8%
    0
    0%
    8
    9.9%
    Region of Enrollment (participants) [Number]
    United States
    58
    100%
    23
    100%
    81
    100%

    Outcome Measures

    1. Primary Outcome
    Title Proportion of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test
    Description CMH is a test used in the analysis of stratified or matched categorical data. It allows testing of the association between a binary predictor or treatment and a binary outcome such as case or control status while taking into account the stratification
    Time Frame 12 Months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Saxenda Placebo
    Arm/Group Description Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Placebo: Subcutaneous Saline Solution
    Measure Participants 58 23
    Number [percentage of participants]
    67.24
    115.9%
    4.35
    18.9%

    Adverse Events

    Time Frame 1 year
    Adverse Event Reporting Description
    Arm/Group Title Saxenda Placebo
    Arm/Group Description Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Saxenda: Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day Placebo: Subcutaneous Saline Solution
    All Cause Mortality
    Saxenda Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/89 (0%) 0/43 (0%)
    Serious Adverse Events
    Saxenda Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 4/89 (4.5%) 6/43 (14%)
    Gastrointestinal disorders
    ABDOMINAL PAIN 0/89 (0%) 1/43 (2.3%)
    CONSTIPATION 0/89 (0%) 1/43 (2.3%)
    INTERNAL HERNIA 1/89 (1.1%) 0/43 (0%)
    General disorders
    SYNCOPE 0/89 (0%) 2/43 (4.7%)
    Infections and infestations
    HEPATITIS A 1/89 (1.1%) 0/43 (0%)
    SEPTIC SHOCK 1/89 (1.1%) 0/43 (0%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    PAPILLARY THYROID CANCER 0/89 (0%) 1/43 (2.3%)
    Surgical and medical procedures
    SURGERY 1/89 (1.1%) 1/43 (2.3%)
    Other (Not Including Serious) Adverse Events
    Saxenda Placebo
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 40/89 (44.9%) 26/43 (60.5%)
    Cardiac disorders
    HIGH BLOOD PRESSURE 1/89 (1.1%) 0/43 (0%)
    PALPITATIONS 1/89 (1.1%) 0/43 (0%)
    Ear and labyrinth disorders
    VERTIGO 1/89 (1.1%) 0/43 (0%)
    Endocrine disorders
    SWOLLEN SALIVARY GLAND 0/89 (0%) 1/43 (2.3%)
    SWOLLEN THYROID GLAND 0/89 (0%) 1/43 (2.3%)
    Gastrointestinal disorders
    ABDOMINAL PAIN 8/89 (9%) 1/43 (2.3%)
    ACID REFLUX 2/89 (2.2%) 0/43 (0%)
    AGGRAVATED GERD 1/89 (1.1%) 0/43 (0%)
    CONSTIPATION 14/89 (15.7%) 4/43 (9.3%)
    DIARRHEA 4/89 (4.5%) 3/43 (7%)
    FLATULENCE 0/89 (0%) 2/43 (4.7%)
    GASTRITIS 0/89 (0%) 1/43 (2.3%)
    NAUSEA 21/89 (23.6%) 3/43 (7%)
    STOMACH PAIN 1/89 (1.1%) 0/43 (0%)
    VOMITING 3/89 (3.4%) 0/43 (0%)
    General disorders
    BAD MOUTH TASTE 1/89 (1.1%) 0/43 (0%)
    CHEST TIGHTNESS 1/89 (1.1%) 0/43 (0%)
    DECREASED APPETITE 4/89 (4.5%) 0/43 (0%)
    DIZZINESS 1/89 (1.1%) 0/43 (0%)
    DRY MOUTH 4/89 (4.5%) 3/43 (7%)
    EXCESSIVE PERSPIRATION 1/89 (1.1%) 0/43 (0%)
    FATIGUE 6/89 (6.7%) 1/43 (2.3%)
    HAIR LOSS 0/89 (0%) 1/43 (2.3%)
    HEADACHE 7/89 (7.9%) 1/43 (2.3%)
    HIGH ENERGY 1/89 (1.1%) 2/43 (4.7%)
    INCREASED ALCOHOL CONSUMPTION 0/89 (0%) 1/43 (2.3%)
    INSOMNIA 3/89 (3.4%) 2/43 (4.7%)
    LACK OF APPETITE 2/89 (2.2%) 0/43 (0%)
    SENSITIVITY TO COLD (LIGHTHEADNES 0/89 (0%) 1/43 (2.3%)
    TIGHT CHEST 1/89 (1.1%) 0/43 (0%)
    Musculoskeletal and connective tissue disorders
    GOUT FLARE 1/89 (1.1%) 0/43 (0%)
    MUSCLE SPASM 1/89 (1.1%) 0/43 (0%)
    Psychiatric disorders
    ANXIETY 1/89 (1.1%) 0/43 (0%)
    MOOD CHANGES - INCREASED IRRITABI 0/89 (0%) 1/43 (2.3%)
    NIGHTTIME BINGE EATING 0/89 (0%) 1/43 (2.3%)
    Renal and urinary disorders
    ABNORMAL KIDNEY FUNCTION 1/89 (1.1%) 0/43 (0%)
    INCREASED CREATININE (AGGRAVATED) 1/89 (1.1%) 0/43 (0%)
    URGENCY TO URINATE 1/89 (1.1%) 0/43 (0%)
    Respiratory, thoracic and mediastinal disorders
    PNEUMONIA 1/89 (1.1%) 0/43 (0%)
    SHORTNESS OF BREATH 1/89 (1.1%) 0/43 (0%)
    Skin and subcutaneous tissue disorders
    BURNING SENSATION AT INJECTION S 1/89 (1.1%) 0/43 (0%)
    INJECTION SITE SWELLING 1/89 (1.1%) 0/43 (0%)
    REDNESS AT INJECTION SITE 0/89 (0%) 1/43 (2.3%)
    Surgical and medical procedures
    ED VISIT 1/89 (1.1%) 0/43 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Holly F. Lofton, MD
    Organization NYU Langone Health - Weight Management Program
    Phone (212) 263-3166
    Email Holly.Lofton@nyulangone.org
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT03048578
    Other Study ID Numbers:
    • 16-01527
    First Posted:
    Feb 9, 2017
    Last Update Posted:
    Mar 22, 2022
    Last Verified:
    Feb 1, 2022