Gastric Emptying of Solids (T1/2)
| Group | Value (minutes) |
|---|---|
| Liraglutide | 191.6 |
| Placebo | 105.9 |
Trial · Interventional
CompletedPhase 2Results postedRegistry dataUnited States
1 trial · 1 completed · 1 with posted results
Pilot Study of the Effect of Liraglutide 3.0 mg on Weight Loss and Gastric Functions in Obesity
NCT0352327329 Nov 2017 to 31 Aug 2021
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.
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.
Outcomes the sponsor listed as primary.
Gastric Emptying of Solids (T1/2)
Time frame · 5 weeks
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.
Gastric Emptying of Solids (T1/2)
Time frame · 16 weeks
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.
Change in Weight at 5 Weeks
Time frame · baseline, 5 weeks
Change in subject's weight, in kilograms
Change in Weight at 16 Weeks
Time frame · baseline, 16 weeks
Change in subject's weight, in kilograms
Satiety
Time frame · 16 weeks
Subjects self-reported fullness after eating as much of a prescribed meal measured by kilocalories of food consumed.
Satiation Volume to Fullness
Time frame · 16 weeks
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).
Maximum Satiation
Time frame · 16 weeks
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).
Fasting Gastric Volume Prior to Meal
Time frame · 16 weeks
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.
Gastric Volume After Meal
Time frame · 16 weeks
Gastric volume was measured after a meal of 300 mL Ensure drink using noninvasive single photon emission-computed tomography (SPECT) of the stomach.
Gastric Accommodation
Time frame · 16 weeks
Measured in milliliters (mL), using the difference between the fasting gastric volume prior to the meal and the gastric volume after the meal.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (minutes) |
|---|---|
| Liraglutide | 191.6 |
| Placebo | 105.9 |
| Group | Value (minutes) |
|---|---|
| Liraglutide | 154.4 |
| Placebo | 111.4 |
| Group | Value (kilograms) |
|---|---|
| Liraglutide | -3.8 |
| Placebo | 0.1 |
| Group | Value (kilograms) |
|---|---|
| Liraglutide | -5.8 |
| Placebo | 0.0 |
| Group | Value (kilocalories) |
|---|---|
| Liraglutide | 647.5 |
| Placebo | 793.7 |
| Group | Value (milliliters (mL)) |
|---|---|
| Liraglutide | 622.1 |
| Placebo | 746.6 |
| Group | Value (milliliters (mL)) |
|---|---|
| Liraglutide | 974.4 |
| Placebo | 1119.8 |
| Group | Value (milliliters (mL)) |
|---|---|
| Liraglutide | 221.2 |
| Placebo | 191.5 |
| Group | Deaths | Serious events | Other 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 / 67 | 1 / 67 | 67 / 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 / 69 | 1 / 69 | 56 / 69 |
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