Phase 4 · Liraglutide

NCT03048578 trial results

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

Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Test (percentage of participants), 12 Months. Saxenda: 76; Placebo: 17.

Participants
132
Status
completed
Completed
2021-03-02
Sponsor
NYU Langone Health

As posted on ClinicalTrials.gov (NCT03048578), updated at source Dec 9, 2022. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT03048578 measured first

Percentage of Participants Losing at Least 5% Enrollment Body Weight Measured Using Cochran-Mantel-Haenszel (CMH) Testpercentage of participants · 12 Months · number
Saxendan=58Placebon=23
7617
Side effects by arm

Side effects in NCT03048578

Percent of participants affected, 1 year. The most common events the registry lists.

EventSaxendaPlacebo
Any serious event4.5%14%
NAUSEA23.6%7%
CONSTIPATION15.7%9.3%
ABDOMINAL PAIN9%2.3%
HEADACHE7.9%2.3%
DIARRHEA4.5%7%
DRY MOUTH4.5%7%
FATIGUE6.7%2.3%
FLATULENCE0%4.7%
HIGH ENERGY1.1%4.7%
INSOMNIA3.4%4.7%
DECREASED APPETITE4.5%0%
VOMITING3.4%0%
GASTRITIS0%2.3%
HAIR LOSS0%2.3%
INCREASED ALCOHOL CONSUMPTION0%2.3%
MOOD CHANGES - INCREASED IRRITABI0%2.3%
NIGHTTIME BINGE EATING0%2.3%
REDNESS AT INJECTION SITE0%2.3%
SENSITIVITY TO COLD (LIGHTHEADNES0%2.3%
SWOLLEN SALIVARY GLAND0%2.3%
SWOLLEN THYROID GLAND0%2.3%
ACID REFLUX2.2%0%
LACK OF APPETITE2.2%0%
ABNORMAL KIDNEY FUNCTION1.1%0%
AGGRAVATED GERD1.1%0%
The trial

How NCT03048578 was run

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.

  • 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
  • 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
Who could join the trial

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

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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