parallel randomized trial

NCT04311411

Effect of Tirzepatide on Energy Intake and Appetite-and Reward-Related Brain Areas in Overweight/Obese Subjects: A Placebo-Controlled 6-Week Study With Functional MRI

Overweight or obesity without diabetes (adults)NCT04311411S000411

Design

Randomized: 114
Start year: 2020
Treatment: 6 weeks, follow-up 10 weeks
Countries: United States (3 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults 18 to 65, BMI 27 to 50, no diabetes, HbA1c below 6.5

Conduct and analysis

Blinding: double blind
Sequence generation: not reported
Allocation concealment: not reported
Outcome adjudication: not reported
Primary estimand: not stated
Analysis population: randomized
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized
A1	Placebo Placebo	lifestyle: none	39
A2	Liraglutide 3.0 mg subcutaneous once daily Liraglutide 3 mg	lifestyle: none	38
A3	Tirzepatide 10 mg subcutaneous once weekly Tirzepatide 10 mg	lifestyle: none	37

Baseline characteristics

As printed in the trial reports or registry, per arm or for the whole trial.

Characteristic	Statistic	Placebo A1	Liraglutide 3.0 mg subcutaneous once daily A2	Tirzepatide 10 mg subcutaneous once weekly A3
age	mean (years)	46.2	43.7	44.8
age	sd (years)	9.5	11.9	10.2
asian	n	0	0	0
black	n	11	10	9
black	percent	28	26	24
bmi	mean (kg/m2)	36.2	36.2	36.1
bmi	sd (kg/m2)	5.9	5.4	5.7
female	n	36	25	36
female	percent	92	66	97
hispanic	n	2	3	0
hispanic	percent	5	8
waist	mean (cm)	110.3	110.7	109.8
waist	sd (cm)	14.3	14.5	12.2
weight	mean (kg)	98.2	101.1	97.6
weight	sd (kg)	20.8	19.5	16.0
white	n	28	28	27
white	percent	72	74	73

Analyses this trial contributes to

Results

24 adjudicated result lines, grouped by outcome. Open an outcome to see its values.

All cause mortality (3 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; safety; R0012789:Results
A2	events	0 / 38	not stated; safety; R0012789:Results
A3	events	0 / 37	not stated; safety; R0012789:Results

Serious adverse events (3 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; safety; registry:adverse_events
A2	events	1 / 38	not stated; safety; R0012789:Results
A3	events	0 / 37	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (3 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	2 / 39	not stated; safety; R0012789:Results
A2	events	2 / 38	not stated; safety; R0012789:Results
A3	events	3 / 37	not stated; safety; R0012789:Results

Nausea (3 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	2 / 39	not stated; safety; registry:adverse_events
A2	events	11 / 38	not stated; safety; registry:adverse_events
A3	events	19 / 37	not stated; safety; registry:adverse_events

Vomiting (3 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	1 / 39	not stated; safety; registry:adverse_events
A2	events	4 / 38	not stated; safety; registry:adverse_events
A3	events	11 / 37	not stated; safety; registry:adverse_events

Diarrhea (3 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	2 / 39	not stated; safety; registry:adverse_events
A2	events	1 / 38	not stated; safety; registry:adverse_events
A3	events	5 / 37	not stated; safety; registry:adverse_events

Constipation (3 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 39	not stated; safety; registry:adverse_events
A2	events	5 / 38	not stated; safety; registry:adverse_events
A3	events	7 / 37	not stated; safety; registry:adverse_events

Discontinuation due to gastrointestinal adverse events (3 lines; O27E)

Arm	Statistic	Events / N	Detail
A2	events	1 / 38	not stated; safety; vomiting; R0012789:Results
A3	events	1 / 37	not stated; safety; nausea; R0012789:Results
A3	events	1 / 37	not stated; safety; vomiting; R0012789:Results