parallel randomized trial

NCT06584916

A Phase 3b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Orforglipron Once Daily Versus Placebo for Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

Weight maintenance after a GLP-1 receptor agonist containing run in NCT06584916S001469

Design

Randomized: 376
Start year: 2024
Treatment: 52 weeks, follow-up 54 weeks
Countries: United States (29 sites)
Sponsor: Eli Lilly (industry)
Eligibility: adults without diabetes who completed SURMOUNT-5 on treatment with at least 5 percent weight loss; BMI above 22

Conduct and analysis

Blinding: double blind
Sequence generation: computer
Allocation concealment: central
Outcome adjudication: yes
Primary estimand: treatment policy
Analysis population: modified itt
Missing data: imputation

Arms

Arm	Treatment	Background	Randomized
A1	orforglipron Cohort 1 (after tirzepatide) orforglipron 36 mg or MTD	lifestyle: standard	125
A2	Placebo Cohort 1 (after tirzepatide) placebo	lifestyle: standard	80
A3	orforglipron Cohort 2 (after semaglutide) orforglipron 36 mg or MTD	lifestyle: standard	105
A4	Placebo Cohort 2 (after semaglutide) placebo	lifestyle: standard	66

Baseline characteristics

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

Characteristic	Statistic	Cohort 1 (after tirzepatide) orforglipron 36 mg or MTD A1	Placebo A2	Cohort 2 (after semaglutide) orforglipron 36 mg or MTD A3	Placebo A4
age	mean (years)	49.0	47.7	48.6	48.7
age	sd (years)	12.6	11.8	11.8	13.5
asian	n	1	4	1	2
black	n	26	16	27	9
bmi	mean (kg/m2)	31.6	30.7	33.2	33.1
bmi	sd (kg/m2)	6.8	6.0	7.6	7.5
egfr	mean (mL/min/1.73 m2)	94.1	94.8	91.9	94.6
egfr	sd (mL/min/1.73 m2)	19.7	16.2	21.0	18.8
female	n	79	50	73	44
female	percent	63.2	62.5	69.5	66.7
hba1c	mean (percent)	5.2	5.1	5.2	5.3
hba1c	sd (percent)	0.3	0.3	0.4	0.4
other prediabetes	n	6	6	13	13
other prediabetes	percent	4.8	7.5	12.4	19.7
sbp	mean (mmHg)	113.5	116.0	117.7	115.8
sbp	sd (mmHg)	12.8	13.9	12.6	13.9
waist	mean (cm)	100.3	98.9	103.4	102.2
waist	sd (cm)	16.6	15.3	18.7	18.4
weight	mean (kg)	90.8	88.8	95.0	93.4
weight	sd (kg)	23.5	21.5	25.7	25.6
white	n	94	55	74	55

Analyses this trial contributes to

Results

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

Acute kidney injury (4 lines; O121)

Arm	Statistic	Events / N	Detail
A1	events	0 / 124	hypothetical; safety; R0004461:Table 2
A2	events	0 / 80	hypothetical; safety; R0004461:Table 2
A3	events	0 / 105	hypothetical; safety; R0004461:Table 2
A4	events	0 / 66	hypothetical; safety; R0004461:Table 2

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	3 / 124	hypothetical; safety; R0004461:Table 2
A2	events	0 / 80	hypothetical; safety; R0004461:Table 2
A3	events	1 / 105	hypothetical; safety; R0004461:Table 2
A4	events	1 / 66	hypothetical; safety; R0004461:Table 2

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	9 / 124	hypothetical; safety; R0004461:Table 2
A2	events	2 / 80	hypothetical; safety; R0004461:Table 2
A3	events	5 / 105	hypothetical; safety; R0004461:Table 2
A4	events	2 / 66	hypothetical; safety; R0004461:Table 2

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	29 / 124	hypothetical; safety; R0004461:Table 2
A2	events	4 / 80	hypothetical; safety; R0004461:Table 2
A3	events	14 / 105	hypothetical; safety; R0004461:Table 2
A4	events	2 / 66	hypothetical; safety; R0004461:Table 2

Vomiting (4 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	14 / 124	hypothetical; safety; R0004461:Table 2
A2	events	1 / 80	hypothetical; safety; R0004461:Table 2
A3	events	5 / 105	hypothetical; safety; R0004461:Table 2
A4	events	4 / 66	hypothetical; safety; R0004461:Table 2

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	9 / 124	hypothetical; safety; R0004461:Table 2
A2	events	9 / 80	hypothetical; safety; R0004461:Table 2
A3	events	8 / 105	hypothetical; safety; R0004461:Table 2
A4	events	2 / 66	hypothetical; safety; R0004461:Table 2

Constipation (4 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	15 / 124	hypothetical; safety; R0004461:Table 2
A2	events	4 / 80	hypothetical; safety; R0004461:Table 2
A3	events	15 / 105	hypothetical; safety; R0004461:Table 2
A4	events	2 / 66	hypothetical; safety; R0004461:Table 2

Discontinuation due to gastrointestinal adverse events (4 lines; O27E)

Arm	Statistic	Events / N	Detail
A1	events	3 / 124	hypothetical; safety; R0004461:Table 2
A2	events	0 / 80	hypothetical; safety; R0004461:Table 2
A3	events	1 / 105	hypothetical; safety; R0004461:Table 2
A4	events	0 / 66	hypothetical; safety; R0004461:Table 2

Gallbladder and biliary disease (8 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 124	hypothetical; safety; cholelithiasis; R0004461:Table 2
A1	events	0 / 124	hypothetical; safety; R0004461:Table 2
A2	events	0 / 80	hypothetical; safety; R0004461:Table 2
A2	events	0 / 80	hypothetical; safety; cholelithiasis; R0004461:Table 2
A3	events	0 / 105	hypothetical; safety; cholelithiasis; R0004461:Table 2
A3	events	0 / 105	hypothetical; safety; R0004461:Table 2
A4	events	0 / 66	hypothetical; safety; R0004461:Table 2
A4	events	1 / 66	hypothetical; safety; cholelithiasis; R0004461:Table 2

Acute pancreatitis (4 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	1 / 124	hypothetical; safety; R0004461:Table 2
A2	events	0 / 80	hypothetical; safety; R0004461:Table 2
A3	events	0 / 105	hypothetical; safety; R0004461:Table 2
A4	events	0 / 66	hypothetical; safety; R0004461:Table 2

Suicidal ideation or behavior (4 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	0 / 124	hypothetical; safety; R0004461:Table 2
A2	events	0 / 80	hypothetical; safety; R0004461:Table 2
A3	events	0 / 105	hypothetical; safety; R0004461:Table 2
A4	events	0 / 66	hypothetical; safety; R0004461:Table 2

Any cancer (4 lines; O39)

Arm	Statistic	Events / N	Detail
A1	events	1 / 124	hypothetical; safety; R0004461:Table 2
A2	events	0 / 80	hypothetical; safety; R0004461:Table 2
A3	events	0 / 105	hypothetical; safety; R0004461:Table 2
A4	events	0 / 66	hypothetical; safety; R0004461:Table 2