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Trial · Interventional

CompletedPhase 2Results postedRegistry data

Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity

NCTNCT03523273 (opens ClinicalTrials.gov in a new tab)Other id15-001783 Part BOther idR56DK067071Other idUL1TR000135

Overview

Status
Completed
Phase
Phase 2
Enrollment
136 participants (actual)
Sponsor
Michael Camilleri, MD · Other
Design
Randomized · Double masking
Countries
1 country

United States

Start
29 Nov 2017
Primary completion
31 Aug 2021
Completion
31 Aug 2021
First posted
14 May 2018
Last update posted
23 Jun 2022
Conditions
Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201720182019202020212022
  1. Ph 2

    Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity

    NCT03523273

    29 Nov 2017 to 31 Aug 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study is being done to assess the stomach emptying effect of a maximum dose of 3 mg Liraglutide compared to placebo in subjects who are overweight or obese. Liraglutide is a medication approved by the Food and Drug Administration (FDA) for routine clinical use.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Liraglutide

    Liraglutide initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.

  • Experimental

    Placebo

    Placebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Gastric Emptying of Solids (T1/2)

    Time frame · 5 weeks

    Registry description

    The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.

  2. Gastric Emptying of Solids (T1/2)

    Time frame · 16 weeks

    Registry description

    The time for half of the ingested solids to leave the stomach. Following a meal consisting of two eggs labeled with technetium Tc 99m sulfur colloid (1 mCi), gastric emptying of solids was assessed with scintigraphy imaging.

Secondary outcomes(8)
  1. Change in Weight at 5 Weeks

    Time frame · baseline, 5 weeks

    Registry description

    Change in subject's weight, in kilograms

  2. Change in Weight at 16 Weeks

    Time frame · baseline, 16 weeks

    Registry description

    Change in subject's weight, in kilograms

  3. Satiety

    Time frame · 16 weeks

    Registry description

    Subjects self-reported fullness after eating as much of a prescribed meal measured by kilocalories of food consumed.

  4. Satiation Volume to Fullness

    Time frame · 16 weeks

    Registry description

    Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until self-reported fullness and volume consumed will be measured in milliliters (mL).

  5. Maximum Satiation

    Time frame · 16 weeks

    Registry description

    Subjects ingest Ensure 300mL drink meal at a constant rate of 30mL/min until they reach maximum or unbearable fullness. Volume consumed will be measured in milliliters (mL).

  6. Fasting Gastric Volume Prior to Meal

    Time frame · 16 weeks

    Registry description

    Gastric fasting volume was measured prior to a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.

  7. Gastric Volume After Meal

    Time frame · 16 weeks

    Registry description

    Gastric volume was measured after a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.

  8. Gastric Accommodation

    Time frame · 16 weeks

    Registry description

    Measured in milliliters (mL), using the difference between the fasting gastric volume prior to the meal and the gastric volume after the meal.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 5 weeks

Gastric Emptying of Solids (T1/2)

GroupValue (minutes)
Liraglutide191.6
Placebo105.9
Primary outcomeMedian· 16 weeks

Gastric Emptying of Solids (T1/2)

GroupValue (minutes)
Liraglutide154.4
Placebo111.4
Secondary and other outcome results(6)
Secondary outcomeMedian· baseline, 5 weeks

Change in Weight at 5 Weeks

GroupValue (kilograms)
Liraglutide-3.8
Placebo0.1
Secondary outcomeMedian· baseline, 16 weeks

Change in Weight at 16 Weeks

GroupValue (kilograms)
Liraglutide-5.8
Placebo0.0
Secondary outcomeMedian· 16 weeks

Satiety

GroupValue (kilocalories)
Liraglutide647.5
Placebo793.7
Secondary outcomeMedian· 16 weeks

Satiation Volume to Fullness

GroupValue (milliliters (mL))
Liraglutide622.1
Placebo746.6
Secondary outcomeMedian· 16 weeks

Maximum Satiation

GroupValue (milliliters (mL))
Liraglutide974.4
Placebo1119.8
Secondary outcomeMedian· 16 weeks

Fasting Gastric Volume Prior to Meal

GroupValue (milliliters (mL))
Liraglutide221.2
Placebo191.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
LiraglutideLiraglutide initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.0 / 671 / 6767 / 67
PlaceboPlacebo initiated at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6 mg/day in weekly intervals to a dose of 3.0 mg/day is achieved. Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.0 / 691 / 6956 / 69

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Overweight and obese adults (≥30 kg/m\^2 or ≥27 kg/m\^2 with an obesity-related co-morbidity). * Subjects residing within 125 miles of Mayo Clinic in Rochester, Minnesota. * Healthy individuals with no unstable psychiatric disease and not currently on treatment for cardiac, pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, or endocrine (other than hyperglycemia type 2 diabetes mellitus on metformin) disorders. * The investigators plan to recruit equal proportions of men and women. * Women of childbearing potential will be using an effective form of contraception, and have negative pregnancy tests within 48 hours of enrollment and before each radiation exposure. In addition, since liraglutide 3.0 mg is classified as Pregnancy Category X, monthly urine pregnancy testing will be performed in any female participant with childbearing potential. * Subjects must have the ability to provide informed consent before any trial-related activities. Exclusion Criteria: * Weight exceeding 137 kilograms (safety limit of camera for measuring gastric volumes). * Abdominal surgery other than appendectomy, cholecystectomy, Caesarian section or tubal ligation. * Positive history of chronic gastrointestinal diseases, systemic disease that could affect gastrointestinal motility, or use of medications that may alter gastrointestinal motility, appetite or absorption, e.g., orlistat. * Patients with a personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia-type 2. * Patients with a past or current history of pancreatitis, gallstones, history of alcoholism, blood triglyceride levels \>500 mg/dL. * Significant untreated psychiatric dysfunction based upon screening with the Hospital Anxiety and Depression Inventory (HAD), a self-administered alcoholism screening test (AUDIT-C), and the Questionnaire on Eating and Weight Patterns (binge eating disorders and bulimia). If such a dysfunction is identified by a HAD score \>11 on either the Anxiety or Depression subscales, or difficulties with substance or eating disorders, the participant will be excluded and given a referral letter to his/her primary care doctor for further appraisal and follow-up. * Intake of any medication (except multivitamins), within 7 days of the study. Exceptions are birth control pill, estrogen replacement therapy, thyroxin replacement therapy and any medication administered for co-morbidities as long as they do not alter gastrointestinal motility including gastric emptying (GE) and gastric accommodation. For example, statins for hyperlipidemia, diuretics, β-adrenergic blockers, Angiotensin Converting Enzyme (ACE) inhibitors and angiotensin antagonists for hypertension, and metformin for type 2 diabetes mellitus or prediabetes are permissible. In contrast, resin sequestrants for hyperlipidemia (which may reduce GE and reduce appetite, α2-adrenergic agonists for hypertension, or other glucagon-like peptide-1 receptor agonists (GLP-1) receptor agonists (exenatide) or amylin analogs (pramlintide) are not permissible because they significantly affect GE and/or gastric accommodation. * Delayed gastric emptying at 2 and 4 hours * Hypersensitivity to the study medication, liraglutide * Participate in highly intense physical activity program that could potentially interfere with study interpretation.

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