parallel randomized trial

NCT04081337

A Randomized, Placebo-Controlled, Parallel-Arm Study to Investigate the Effect of Once-Weekly Tirzepatide on Energy Expenditure and Food Intake in Obese Subjects

Overweight or obesity without diabetes (adults)NCT04081337S000078

Design

Randomized: 55
Start year: 2020
Treatment: 18 weeks, follow-up 22 weeks
Countries: United States (1 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: age 18 to 60; BMI 30 to 45; no diabetes; at least one metabolic impairment

Conduct and analysis

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

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Placebo Placebo	dietary intervention targeting 10 percent weight loss; lifestyle: intensive	28	28
A2	Tirzepatide 15 mg subcutaneous once weekly Tirzepatide 15 mg	dietary intervention targeting 10 percent weight loss; lifestyle: intensive	27	27

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Tirzepatide 15 mg subcutaneous once weekly A2
age	mean (years)	48.1	45.5
age	sd (years)	10.7	9.8
asian	n	0	0
black	n	12	11
black	percent	42.9	40.7
bmi	mean (kg/m2)	37.4	36.8
bmi	sd (kg/m2)	4.2	3.9
female	n	24	22
female	percent	85.7	81.5
other race multiple	n	1	2
other race multiple	percent	3.6	7.4
waist	mean (cm)	111.7	110.7
waist	sd (cm)	8.4	12.9
weight	mean (kg)	103.1	102.5
weight	sd (kg)	12.6	15.1
white	n	15	14
white	percent	53.6	51.9

Analyses this trial contributes to

Results

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

Percent body weight change (2 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
18	A1	percent change	-8 percent				not stated; modified itt; R0015946:Results
18	A2	percent change	-17 percent				not stated; modified itt; R0015946:Results

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; randomized; R0004227:Supplement Table S1
	A2	events				0 / 27	not stated; safety; registry:adverse_events

Hospitalization for heart failure (2 lines; O23)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; randomized; R0004227:Supplement Table S1
	A2	events				0 / 27	not stated; randomized; R0004227:Supplement Table S1

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; randomized; R0004227:Supplement Table S1
	A2	events				1 / 27	not stated; randomized; R0004227:Supplement Table S1

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 28	not stated; randomized; registry:flow
A1	events	0 / 28	not stated; randomized; nausea; R0004227:Supplement Table S1
A2	events	1 / 27	not stated; randomized; R0004227:Figure 2C
A2	events	1 / 27	not stated; randomized; nausea; R0004227:Supplement Table S1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				7 / 28	not stated; randomized; R0004227:Supplement Table S1
	A2	events				14 / 27	not stated; randomized; R0004227:Supplement Table S1

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 28	not stated; randomized; R0004227:Supplement Table S1
	A2	events				7 / 27	not stated; randomized; R0004227:Supplement Table S1

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 28	not stated; randomized; R0004227:Supplement Table S1
	A2	events				6 / 27	not stated; randomized; R0004227:Supplement Table S1

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				4 / 28	not stated; randomized; R0004227:Supplement Table S1
	A2	events				10 / 27	not stated; randomized; R0004227:Supplement Table S1

Discontinuation due to gastrointestinal adverse events (2 lines; O27E)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; randomized; nausea; R0004227:Supplement Table S1
	A2	events				1 / 27	not stated; randomized; nausea; R0004227:Supplement Table S1

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; randomized; cholelithiasis; R0004227:Supplement Table S1
	A2	events				1 / 27	not stated; randomized; cholelithiasis; R0004227:Supplement Table S1

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; randomized; pancreatitis; R0004227:Supplement Table S1
	A2	events				1 / 27	not stated; randomized; pancreatitis; R0004227:Supplement Table S1

Death by suicide (2 lines; O35B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 28	not stated; randomized; R0004227:Supplement Table S1
	A2	events				0 / 27	not stated; safety; registry:adverse_events