19

Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure

  • Upload
    others

  • View
    1

  • Download
    0

Embed Size (px)

Citation preview

Page 1: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 2: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 3: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 4: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 5: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 6: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 7: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 8: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 9: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 10: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 11: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 12: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 13: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 14: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure

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

Page 15: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 16: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure

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

Page 17: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure
Page 18: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure

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)

Page 19: Plenity® | Feel fuller to help you lose weight - Instructions for Use … · 2020-04-28 · Failure to adhere to prescribed dietary and exercise instructions may result in failure