1. Product Vision/Value Proposition:
Draft TPP
1
Minimum Profile Target Profile Optimistic Profile
Indication Mounjaro® (mown-JAHR-OH) is an Mounjaro® (mown-JAHR-OH) is an
injectable medicine for adults with injectable medicine for adults with
type 2 diabetes used along with diet type 2 diabetes used along with diet
and exercise to improve and exercise to improve
blood sugar (glucose) blood sugar (glucose)
Mechanism of
Action
It works to stimulate first- and It works to stimulate first- and
second-phase insulin secretion, second-phase insulin secretion,
and reduces glucagon levels, both and reduces glucagon levels, both
in a glucose-dependent manner. in a glucose-dependent manner.
Tirzepatide was also shown to delay Tirzepatide was also shown to delay
gastric emptying, lower fasting and gastric emptying, lower fasting and
postprandial glucose concentration, postprandial glucose concentration,
decrease food intake, and reduce decrease food intake, and reduce.
body weight in patients with type 2 diabetes body weight in patients with type 2 diabetes
Study Design Control trial
2. Draft TPP (cont’d)
2
Minimum Profile Target Profile Optimistic Profile
Dosing 2.5 mg once weekly for 4
weeks. Continue to 5 mg once weekly
for at least 4 weeks.
2.5 mg SC qWeek x 4 weeks initially;
THEN increase to 5 mg SC qWeek
If additional glycemic control needed,
increase by 2.5-mg increments after
at least 4 weeks at current dose
Maximum dose: 15 mg SC qWeek
Route injection under the skin once weekly injection under the skin once weekly
(sc)
Frequency 2.5 mg injected subcutaneously once
weekly
2.5 mg injected subcutaneously
once weekly
Presentation/Strengt
h
2.5mg, 5mg, 7mg, 10mg, 12.5mg 2.5mg/0.5mL ,5mg/0.5mL
, and 15mg as a once weekly 7.5mg/0.5mL, 12.5mg/0.5mL
15mg/0.5mL
Administration once weekly, any time of day, with or
without meals.
once weekly, any time of day, with or
without meals.
