parallel randomized trial

NCT05051579

A Phase 2 Study of Once-Daily LY3502970 Compared With Placebo in Participants Who Have Obesity or Are Overweight With Weight-Related Comorbidities

Overweight or obesity without diabetes (adults)NCT05051579S002337

Design

Randomized: 272
Start year: 2021
Treatment: 36 weeks, follow-up 38 weeks
Countries: Canada, Hungary, United States
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults BMI 30 or more, or 27 to 30 with a weight related complication, without diabetes

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: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Orforglipron 12 mg oral once daily Orforglipron 12 mg	lifestyle: standard	50	44
A2	Orforglipron 24 mg oral once daily Orforglipron 24 mg	lifestyle: standard	53	51
A3	Orforglipron 36 mg oral once daily Orforglipron 36 mg cohort 1	lifestyle: standard	29
A4	Orforglipron 36 mg oral once daily Orforglipron 36 mg cohort 2	lifestyle: standard	29
A5	Orforglipron 45 mg oral once daily Orforglipron 45 mg cohort 1	lifestyle: standard	31
A6	Orforglipron 45 mg oral once daily Orforglipron 45 mg cohort 2	lifestyle: standard	30
A7	Placebo Placebo	lifestyle: standard	50	48

Baseline characteristics

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

Characteristic	Statistic	Orforglipron 12 mg oral once daily A1	Orforglipron 24 mg oral once daily A2	Orforglipron 36 mg oral once daily A3	Orforglipron 36 mg oral once daily A4	Orforglipron 45 mg oral once daily A5	Orforglipron 45 mg oral once daily A6	Placebo A7
age	mean (years)	49.80	57.00	56.30	55.40	56.50	50.90	54.00
age	sd (years)	10.51	9.09	11.83	10.93	10.74	12.58	8.82
asian	n	0	0	0	0	0	0	2
black	n	3	6	4	4	1	0	1
bmi	mean (kg/m2)	38.0	38.7					37.5
bmi	sd (kg/m2)	8.1	8.2					6.0
female	n	31	30	18	18	19	16	29
hispanic	n	11	6	4	2	4	7	5
other american indian alaska native	n	0	1	0	0	0	0	0
waist	mean (cm)	114.8	120.9					114.8
waist	sd (cm)	17.5	20.6					14.3
weight	mean (kg)	107.49	112.05	107.78	108.84	105.23	110.85	107.57
weight	sd (kg)	25.34	30.18	22.45	28.52	20.40	28.11	25.24
white	n	47	46	25	25	29	30	45

Analyses this trial contributes to

Results

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

Systolic blood pressure change (9 lines; O05)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
36	A1	change	-7.1 mmHg	-10.3 to -3.9	42	hypothetical; modified itt; R0004295:Supplement Table 2
36	A1 vs A7	md	-5.2 mmHg	-9.7 to -0.7		hypothetical; modified itt; R0004295:Supplement Table 2
36	A2	change	-6.5 mmHg	-9.7 to -3.3	41	hypothetical; modified itt; R0004295:Supplement Table 2
36	A2 vs A7	md	-4.5 mmHg	-9.0 to -0.1		hypothetical; modified itt; R0004295:Supplement Table 2
36	A3	change	-10.0 mmHg	-13.0 to -7.0	47	hypothetical; modified itt; R0004295:Supplement Table 2
36	A3 vs A7	md	-8.1 mmHg	-12.5 to -3.8		hypothetical; modified itt; R0004295:Supplement Table 2
36	A5	change	-10.6 mmHg	-13.6 to -7.6	46	hypothetical; modified itt; R0004295:Supplement Table 2
36	A5 vs A7	md	-8.7 mmHg	-13.0 to -4.3		hypothetical; modified itt; R0004295:Supplement Table 2
36	A7	change	-1.9 mmHg	-5.0 to 1.2	43	hypothetical; modified itt; R0004295:Supplement Table 2

Percent body weight change (18 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
26	A1	percent change	-8.6 percent	0.85		44	not stated; modified itt; registry:outcomes
26	A1 vs A7	md	-6.5 percent		-8.9 to -4.2		not stated; modified itt; registry:outcomes
26	A2	percent change	-11.2 percent	0.82		51	not stated; modified itt; registry:outcomes
26	A2 vs A7	md	-9.2 percent		-11.5 to -6.9		not stated; modified itt; registry:outcomes
26	A3	percent change	-12.3 percent	0.77		56	not stated; modified itt; registry:outcomes
26	A3 vs A7	md	-10.2 percent		-12.4 to -8.0		not stated; modified itt; registry:outcomes
26	A5	percent change	-12.6 percent	0.75		57	not stated; modified itt; registry:outcomes
26	A5 vs A7	md	-10.6 percent		-12.7 to -8.4		not stated; modified itt; registry:outcomes
26	A7	percent change	-2.0 percent	0.81		48	not stated; modified itt; registry:outcomes
36	A1	percent change	-9.4 percent	1.05		44	not stated; modified itt; registry:outcomes
36	A1 vs A7	md	-7.1 percent		-9.9 to -4.2		not stated; modified itt; registry:outcomes
36	A2	percent change	-12.5 percent	1.01		51	not stated; modified itt; registry:outcomes
36	A2 vs A7	md	-10.1 percent		-12.9 to -7.3		not stated; modified itt; registry:outcomes
36	A3	percent change	-13.5 percent	0.95		56	not stated; modified itt; registry:outcomes
36	A3 vs A7	md	-11.1 percent		-13.8 to -8.4		not stated; modified itt; registry:outcomes
36	A5	percent change	-14.7 percent	0.94		57	not stated; modified itt; registry:outcomes
36	A5 vs A7	md	-12.3 percent		-15.0 to -9.6		not stated; modified itt; registry:outcomes
36	A7	percent change	-2.3 percent	1.00		48	not stated; modified itt; registry:outcomes

Weight loss of 5 percent or more (18 lines; O11A)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	74.39		44	not stated; modified itt; registry:outcomes
26	A1 vs A7	or	9.96	3.61 to 27.44		not stated; modified itt; registry:outcomes
26	A2	responders	88.84		51	not stated; modified itt; registry:outcomes
26	A2 vs A7	or	27.97	8.15 to 96.01		not stated; modified itt; registry:outcomes
26	A3	responders	89.46		56	not stated; modified itt; registry:outcomes
26	A3 vs A7	or	27.36	8.71 to 85.91		not stated; modified itt; registry:outcomes
26	A5	responders	87.26		57	not stated; modified itt; registry:outcomes
26	A5 vs A7	or	23.59	7.65 to 72.77		not stated; modified itt; registry:outcomes
26	A7	responders	22.88		48	not stated; modified itt; registry:outcomes
36	A1	responders	72.00		44	not stated; modified itt; registry:outcomes
36	A1 vs A7	or	7.79	2.90 to 20.92		not stated; modified itt; registry:outcomes
36	A2	responders	89.47		51	not stated; modified itt; registry:outcomes
36	A2 vs A7	or	25.07	7.49 to 83.91		not stated; modified itt; registry:outcomes
36	A3	responders	92.05		56	not stated; modified itt; registry:outcomes
36	A3 vs A7	or	34.76	8.17 to 147.86		not stated; modified itt; registry:outcomes
36	A5	responders	90.44		57	not stated; modified itt; registry:outcomes
36	A5 vs A7	or	28.01	8.15 to 96.29		not stated; modified itt; registry:outcomes
36	A7	responders	24.02		48	not stated; modified itt; registry:outcomes

Weight loss of 10 percent or more (18 lines; O11B)

Week	Arm	Statistic	Estimate	95% CI	Events / N	Detail
26	A1	responders	39.39		44	not stated; modified itt; registry:outcomes
26	A1 vs A7	or	19.93	3.47 to 114.40		not stated; modified itt; registry:outcomes
26	A2	responders	56.61		51	not stated; modified itt; registry:outcomes
26	A2 vs A7	or	39.52	6.95 to 224.83		not stated; modified itt; registry:outcomes
26	A3	responders	71.30		56	not stated; modified itt; registry:outcomes
26	A3 vs A7	or	74.97	13.16 to 427.18		not stated; modified itt; registry:outcomes
26	A5	responders	69.86		57	not stated; modified itt; registry:outcomes
26	A5 vs A7	or	72.23	12.62 to 413.21		not stated; modified itt; registry:outcomes
26	A7	responders	2.25		48	not stated; modified itt; registry:outcomes
36	A1	responders	46.50		44	not stated; modified itt; registry:outcomes
36	A1 vs A7	or	8.27	2.59 to 26.45		not stated; modified itt; registry:outcomes
36	A2	responders	61.88		51	not stated; modified itt; registry:outcomes
36	A2 vs A7	or	15.64	4.83 to 50.68		not stated; modified itt; registry:outcomes
36	A3	responders	74.75		56	not stated; modified itt; registry:outcomes
36	A3 vs A7	or	27.24	8.39 to 88.38		not stated; modified itt; registry:outcomes
36	A5	responders	69.07		57	not stated; modified itt; registry:outcomes
36	A5 vs A7	or	20.88	6.59 to 66.17		not stated; modified itt; registry:outcomes
36	A7	responders	8.85		48	not stated; modified itt; registry:outcomes

All cause mortality (7 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	0 / 50	not stated; safety; registry:adverse_events
A2	events	0 / 53	not stated; safety; registry:adverse_events
A3	events	0 / 29	not stated; safety; registry:adverse_events
A4	events	0 / 29	not stated; safety; registry:adverse_events
A5	events	0 / 31	not stated; safety; registry:adverse_events
A6	events	0 / 30	not stated; safety; registry:adverse_events
A7	events	0 / 50	not stated; safety; registry:adverse_events

Serious adverse events (7 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	0 / 50	not stated; safety; registry:adverse_events
A2	events	2 / 53	not stated; safety; registry:adverse_events
A3	events	0 / 29	not stated; safety; registry:adverse_events
A4	events	3 / 29	not stated; safety; registry:adverse_events
A5	events	2 / 31	not stated; safety; registry:adverse_events
A6	events	0 / 30	not stated; safety; registry:adverse_events
A7	events	0 / 50	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (7 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	2 / 50	not stated; randomized; registry:flow
A2	events	1 / 53	not stated; randomized; registry:flow
A3	events	0 / 29	not stated; randomized; registry:flow
A4	events	4 / 29	not stated; randomized; registry:flow
A5	events	1 / 31	not stated; randomized; registry:flow
A6	events	2 / 30	not stated; randomized; registry:flow
A7	events	0 / 50	not stated; randomized; registry:flow

Nausea (7 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	25 / 50	not stated; safety; registry:adverse_events
A2	events	31 / 53	not stated; safety; registry:adverse_events
A3	events	12 / 29	not stated; safety; registry:adverse_events
A4	events	14 / 29	not stated; safety; registry:adverse_events
A5	events	13 / 31	not stated; safety; registry:adverse_events
A6	events	11 / 30	not stated; safety; registry:adverse_events
A7	events	5 / 50	not stated; safety; registry:adverse_events

Vomiting (7 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	13 / 50	not stated; safety; registry:adverse_events
A2	events	17 / 53	not stated; safety; registry:adverse_events
A3	events	8 / 29	not stated; safety; registry:adverse_events
A4	events	4 / 29	not stated; safety; registry:adverse_events
A5	events	9 / 31	not stated; safety; registry:adverse_events
A6	events	8 / 30	not stated; safety; registry:adverse_events
A7	events	3 / 50	not stated; safety; registry:adverse_events

Diarrhea (7 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	12 / 50	not stated; safety; registry:adverse_events
A2	events	19 / 53	not stated; safety; registry:adverse_events
A3	events	1 / 29	not stated; safety; registry:adverse_events
A4	events	4 / 29	not stated; safety; registry:adverse_events
A5	events	5 / 31	not stated; safety; registry:adverse_events
A6	events	10 / 30	not stated; safety; registry:adverse_events
A7	events	5 / 50	not stated; safety; registry:adverse_events

Constipation (7 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	12 / 50	not stated; safety; registry:adverse_events
A2	events	17 / 53	not stated; safety; registry:adverse_events
A3	events	8 / 29	not stated; safety; registry:adverse_events
A4	events	7 / 29	not stated; safety; registry:adverse_events
A5	events	6 / 31	not stated; safety; registry:adverse_events
A6	events	4 / 30	not stated; safety; registry:adverse_events
A7	events	3 / 50	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (7 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	0 / 50	not stated; safety; cholecystitis acute; registry:adverse_events
A2	events	1 / 53	not stated; safety; cholecystitis acute; registry:adverse_events
A3	events	0 / 29	not stated; safety; cholecystitis acute; registry:adverse_events
A4	events	0 / 29	not stated; safety; cholecystitis acute; registry:adverse_events
A5	events	0 / 31	not stated; safety; cholecystitis acute; registry:adverse_events
A6	events	0 / 30	not stated; safety; cholecystitis acute; registry:adverse_events
A7	events	0 / 50	not stated; safety; cholecystitis acute; registry:adverse_events