Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 ·...
Transcript of Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 ·...
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Weight Loss (ITT-MI)
Plenity™ (n=223)
Placebo (n=213)
169 171
-4.39
-6.41
Wei
ght
Cha
nge
fro
m B
asel
ine,
%
0
-2
-4
-6
-8
-12
0 30 60 90 120 150
Study Day
Weight Loss (ITT-MI)
Plenity™ (n=223)
Placebo (n=213)
169 171
-4.39
-6.41
Wei
ght
Cha
nge
fro
m B
asel
ine,
%
0
-2
-4
-6
-8
-12
0 30 60 90 120 150
Study Day
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Plenity™
Plenity™
Placebo
n = 17
n = 18
GLOW GLOW-EX
GLOW GLOW-EX
0 30 60 90 120 150 180 210 240 270 300 330
Study Day
0
0
-2
-4
-6
-8
-10
-12
0
-2
-4
-6
-8
-10
-12
30 60 90 120 150 180 210 240 270 300 330
Study Day
Cha
nge
in W
eig
htfr
om
Bas
elin
e, %
Cha
nge
in W
eig
htfr
om
Bas
elin
e, %
GLOW-EXStart
GLOW-EXStart
Plenity™
Plenity™
Placebo
n = 17
n = 18
GLOW GLOW-EX
GLOW GLOW-EX
0 30 60 90 120 150 180 210 240 270 300 330
Study Day
0
0
-2
-4
-6
-8
-10
-12
0
-2
-4
-6
-8
-10
-12
30 60 90 120 150 180 210 240 270 300 330
Study Day
Cha
nge
in W
eig
htfr
om
Bas
elin
e, %
Cha
nge
in W
eig
htfr
om
Bas
elin
e, %
GLOW-EXStart
GLOW-EXStart
Plenity™
Plenity™
Placebo
n = 17
n = 18
GLOW GLOW-EX
GLOW GLOW-EX
0 30 60 90 120 150 180 210 240 270 300 330
Study Day
0
0
-2
-4
-6
-8
-10
-12
0
-2
-4
-6
-8
-10
-12
30 60 90 120 150 180 210 240 270 300 330
Study Day
Cha
nge
in W
eig
htfr
om
Bas
elin
e, %
Cha
nge
in W
eig
htfr
om
Bas
elin
e, %
GLOW-EXStart
GLOW-EXStart
Plenity™
Plenity™
Placebo
n = 17
n = 18
GLOW GLOW-EX
GLOW GLOW-EX
0 30 60 90 120 150 180 210 240 270 300 330
Study Day
0
0
-2
-4
-6
-8
-10
-12
0
-2
-4
-6
-8
-10
-12
30 60 90 120 150 180 210 240 270 300 330
Study Day
Cha
nge
in W
eig
htfr
om
Bas
elin
e, %
Cha
nge
in W
eig
htfr
om
Bas
elin
e, %
GLOW-EXStart
GLOW-EXStart
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200
400
600
800
1000
1200
1400
1600
1800
2000
0
200
400
600
800
1000
1200
1400
1600
1800
2000
0
0 2 4 6 8 10 12 14 16 18 20 22 24
Metformin - Fasting (n=24)
Plenity • Metformin - Fasting (n=23)
Nominal Time (hours)
0 2 4 6 8 10 12 14 16 18 20 22 24Nominal Time (hours)
7a: Fasted
7b: Fed
Pla
sma
Co
ncen
trat
ion
(ng
/mL)
Pla
sma
Co
ncen
trat
ion
(ng
/mL)
Metformin - Fed (n=24)
Plenity • Metformin - Fed (n=24)
200
400
600
800
1000
1200
1400
1600
1800
2000
0
200
400
600
800
1000
1200
1400
1600
1800
2000
0
0 2 4 6 8 10 12 14 16 18 20 22 24
Metformin - Fasting (n=24)
Plenity • Metformin - Fasting (n=23)
Nominal Time (hours)
0 2 4 6 8 10 12 14 16 18 20 22 24Nominal Time (hours)
7a: Fasted
7b: Fed
Pla
sma
Co
ncen
trat
ion
(ng
/mL)
Pla
sma
Co
ncen
trat
ion
(ng
/mL)
Metformin - Fed (n=24)
Plenity • Metformin - Fed (n=24)
200
400
600
800
1000
1200
1400
1600
1800
2000
0
200
400
600
800
1000
1200
1400
1600
1800
2000
0
0 2 4 6 8 10 12 14 16 18 20 22 24
Metformin - Fasting (n=24)
Plenity • Metformin - Fasting (n=23)
Nominal Time (hours)
0 2 4 6 8 10 12 14 16 18 20 22 24Nominal Time (hours)
7a: Fasted
7b: Fed
Pla
sma
Co
ncen
trat
ion
(ng
/mL)
Pla
sma
Co
ncen
trat
ion
(ng
/mL)
Metformin - Fed (n=24)
Plenity • Metformin - Fed (n=24)
200
400
600
800
1000
1200
1400
1600
1800
2000
0
200
400
600
800
1000
1200
1400
1600
1800
2000
0
0 2 4 6 8 10 12 14 16 18 20 22 24
Metformin - Fasting (n=24)
Plenity • Metformin - Fasting (n=23)
Nominal Time (hours)
0 2 4 6 8 10 12 14 16 18 20 22 24Nominal Time (hours)
7a: Fasted
7b: Fed
Pla
sma
Co
ncen
trat
ion
(ng
/mL)
Pla
sma
Co
ncen
trat
ion
(ng
/mL)
Metformin - Fed (n=24)
Plenity • Metformin - Fed (n=24)
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