parallel randomized trial

TOGETHER-PsO

Efficacy and Safety of Ixekizumab or Ixekizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderate-to-Severe Plaque Psoriasis and Obesity or Overweight: A Phase 3b, Randomized, Multicenter, Open-Label Study (TOGETHER-PsO)

Overweight or obesity without diabetes (adults)Other conditions NCT06588283S000032

Design

Randomized: 281
Start year: 2024
Treatment: 52 weeks, follow-up 56 weeks
Countries: United States (72 sites)
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults; moderate to severe plaque psoriasis; PASI 12 or more; BMI 30 or more, or 27 to 30 with comorbidity

Conduct and analysis

Blinding: open label
Sequence generation: not reported
Allocation concealment: central
Outcome adjudication: not reported
Primary estimand: hypothetical
Analysis population: modified itt
Missing data: multiple imputation

Arms

Arm	Treatment	Background	Randomized	Analyzed	Completed treatment
A1	Standard care or no added treatment Ixekizumab	ixekizumab two 80 mg injections at week 0, 80 mg Q2W through week 12, then 80 mg Q4W; diet and exercise counseling; lifestyle: standard		136	110
A2	Tirzepatide maximum tolerated dose injection once weekly Ixekizumab plus tirzepatide	ixekizumab two 80 mg injections at week 0, 80 mg Q2W through week 12, then 80 mg Q4W; diet and exercise counseling; lifestyle: standard		138	121

Baseline characteristics

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

Characteristic	Statistic	Standard care or no added treatment A1	Tirzepatide maximum tolerated dose injection once weekly A2
age	mean (years)	45.7	45.6
age	sd (years)	12.5	13.0
asian	n	2	7
asian	percent	1.5	5.1
black	n	8	12
black	percent	5.9	8.7
bmi	mean (kg/m2)	39.2	39.3
bmi	sd (kg/m2)	7.9	10.2
established cvd	n	5	8
established cvd	percent	3.7	5.8
female	n	61	62
female	percent	44.9	44.9
hba1c	mean (percent)	5.8	5.8
hba1c	sd (percent)	0.7	0.8
hispanic	n	56	59
hispanic	percent	41.2	42.8
other bmi 27 to 30	n	12	14
other pasi	mean (points)	19.1	20.4
other pasi	sd (points)	7.1	8.9
other race american indian alaska native	n	2	0
other race american indian alaska native	percent	1.5
other race multiple	n	2	1
other race multiple	percent	1.5	0.7
other type2 diabetes	n	10	20
other type2 diabetes	percent	7.4	14.5
sbp	mean (mmHg)	131.9	133.8
sbp	sd (mmHg)	14.6	14.4
waist	mean (cm)	121.4	119.4
waist	sd (cm)	20.1	19.6
weight	mean (kg)	115.5	112.1
weight	sd (kg)	28.0	29.0
white	n	114	105
white	percent	83.8	76.1

Analyses this trial contributes to

Results

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

Systolic blood pressure change (3 lines; O05)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
36	A1	change	-1.4 mmHg	1.15		136	hypothetical; modified itt; R0014237:Table 2
36	A2	change	-9.9 mmHg	1.09		138	hypothetical; modified itt; R0014237:Table 2
36	A2 vs A1	md	-8.5 mmHg		-11.6 to -5.3		hypothetical; modified itt; R0014237:Table 2

Percent body weight change (3 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
36	A1	percent change	-1.2 percent	0.60		136	hypothetical; modified itt; R0014237:Table 2
36	A2	percent change	-14.6 percent	0.77		138	hypothetical; modified itt; R0014237:Table 2
36	A2 vs A1	md	-13.4 percent		-15.3 to -11.4		hypothetical; modified itt; R0014237:Table 2

Weight loss of 10 percent or more (3 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	responders	9.1	3.8 to 14.5	136	hypothetical; modified itt; R0014237:Table 2
36	A2	responders	69.2	61.1 to 77.3	138	hypothetical; modified itt; R0014237:Table 2
36	A2 vs A1	rd	60.0	50.4 to 69.7		hypothetical; modified itt; R0014237:Table 2

All cause mortality (2 lines; O20)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 134	treatment policy; safety; R0014237:Table 3
	A2	events				0 / 138	treatment policy; safety; R0014237:Table 3

Serious adverse events (2 lines; O25)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				8 / 134	treatment policy; safety; R0014237:Table 3
	A2	events				5 / 138	treatment policy; safety; R0014237:Table 3

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	0 / 136	not stated; modified itt; R0014237:Figure 1
A1	events	2 / 134	treatment policy; safety; R0014237:Table 3
A2	events	5 / 138	treatment policy; safety; R0014237:Table 3
A2	events	3 / 138	not stated; modified itt; R0014237:Figure 1

Nausea (2 lines; O27A)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				3 / 134	treatment policy; safety; R0014237:Table 3
	A2	events				34 / 138	treatment policy; safety; R0014237:Table 3

Vomiting (2 lines; O27B)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 134	treatment policy; safety; R0014237:Table 3
	A2	events				12 / 138	treatment policy; safety; R0014237:Table 3

Diarrhea (2 lines; O27C)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				2 / 134	treatment policy; safety; R0014237:Table 3
	A2	events				20 / 138	treatment policy; safety; R0014237:Table 3

Constipation (2 lines; O27D)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 134	treatment policy; safety; R0014237:Table 3
	A2	events				18 / 138	treatment policy; safety; R0014237:Table 3

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

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				1 / 134	treatment policy; safety; R0014237:Table 3
	A2	events				1 / 138	treatment policy; safety; R0014237:Table 3

Gallbladder and biliary disease (2 lines; O28)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 134	treatment policy; safety; cholecystectomy; R0014237:Table 3
	A2	events				1 / 138	treatment policy; safety; cholecystectomy; R0014237:Table 3

Acute pancreatitis (2 lines; O29)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 134	treatment policy; safety; R0014237:Table 3
	A2	events				1 / 138	treatment policy; safety; R0014237:Table 3

Nonarteritic anterior ischemic optic neuropathy (2 lines; O34)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
	A1	events				0 / 134	treatment policy; safety; optic ischemic neuropathy; R0014237:Table 3
	A2	events				1 / 138	treatment policy; safety; optic ischemic neuropathy; R0014237:Table 3