parallel randomized trial

ATTAIN-1

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

Overweight or obesity without diabetes (adults)NCT05869903S001722

Design

Randomized: 3,127
Start year: 2023
Treatment: 72 weeks, follow-up 74 weeks
Countries: Brazil, China, India, Japan, Slovakia, South Korea, Spain, Taiwan, United States
Sponsor: Eli Lilly and Company (industry)
Eligibility: adults BMI 30 or more, or 27 or more 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: hypothetical
Analysis population: randomized
Missing data: MMRM

Arms

Arm	Treatment	Background	Randomized	Analyzed
A1	Placebo Placebo	lifestyle: not reported	949	949
A2	Orforglipron 6 mg oral once daily Orforglipron 6 mg	lifestyle: not reported	723	723
A3	Orforglipron 12 mg oral once daily Orforglipron 12 mg	lifestyle: not reported	725	725
A4	Orforglipron 36 mg oral once daily Orforglipron 36 mg	lifestyle: not reported	730	730

Baseline characteristics

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

Characteristic	Statistic	Placebo A1	Orforglipron 6 mg oral once daily A2	Orforglipron 12 mg oral once daily A3	Orforglipron 36 mg oral once daily A4	Whole trial ALL
age	mean (years)	45.1	44.9	45.4	44.9
age	sd (years)	11.9	12.1	12.6	11.9
asian	n	267	202	201	214
black	n	72	68	60	67
bmi	mean (kg/m2)					37.0
bmi	sd (kg/m2)					6.5
egfr	mean (mL/min/1.73 m2)					92.7
egfr	sd (mL/min/1.73 m2)					18.6
female	n	608	469	467	465
hba1c	mean (percent)					5.6
hba1c	sd (percent)					0.3
hispanic	n	369	273	275	258
other american indian alaska native	n	4	2	3	2
other pacific islander	n	2	0	1	0
other prediabetes	n	344	258	260	265
waist	mean (cm)					112.4
waist	sd (cm)					14.5
weight	mean (kg)	103.92	103.18	102.18	103.10
weight	sd (kg)	22.03	21.65	21.58	23.15
white	n	539	408	405	394

Analyses this trial contributes to

Results

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

Percent body weight change (21 lines; O10)

Week	Arm	Statistic	Estimate	SE or SD	95% CI	Events / N	Detail
72	A1	percent change	-1.6 percent		-3.2 to 0.1	59	hypothetical; randomized; age:>=65; R0001832:Table 2
72	A1	percent change	-0.87 percent	0.247		949	hypothetical; randomized; registry:outcomes
72	A1	percent change	-0.8 percent		-1.4 to -0.3	890	hypothetical; randomized; age:<65; R0001832:Table 2
72	A2 vs A1	md	-6.9 percent		-7.7 to -6.1		hypothetical; randomized; age:<65; R0001832:Table 2
72	A2 vs A1	md	-6.95 percent		-7.71 to -6.18		hypothetical; randomized; registry:outcomes
72	A2	percent change	-7.9 percent		-10.0 to -5.9	40	hypothetical; randomized; age:>=65; R0001832:Table 2
72	A2	percent change	-7.82 percent	0.302		723	hypothetical; randomized; registry:outcomes
72	A2 vs A1	md	-6.4 percent		-9.0 to -3.7		hypothetical; randomized; age:>=65; R0001832:Table 2
72	A2	percent change	-7.7 percent		-8.3 to -7.1	683	hypothetical; randomized; age:<65; R0001832:Table 2
72	A3	percent change	-11.3 percent		-13.4 to -9.3	51	hypothetical; randomized; age:>=65; R0001832:Table 2
72	A3 vs A1	md	-8.40 percent		-9.22 to -7.58		hypothetical; randomized; registry:outcomes
72	A3	percent change	-9.27 percent	0.335		725	hypothetical; randomized; registry:outcomes
72	A3	percent change	-9.2 percent		-9.9 to -8.5	674	hypothetical; randomized; age:<65; R0001832:Table 2
72	A3 vs A1	md	-8.3 percent		-9.2 to -7.5		hypothetical; randomized; age:<65; R0001832:Table 2
72	A3 vs A1	md	-9.8 percent		-12.4 to -7.1		hypothetical; randomized; age:>=65; R0001832:Table 2
72	A4	percent change	-12.4 percent		-13.1 to -11.6	684	hypothetical; randomized; age:<65; R0001832:Table 2
72	A4	percent change	-12.35 percent	0.364		730	hypothetical; randomized; registry:outcomes
72	A4 vs A1	md	-11.48 percent		-12.35 to -10.61		hypothetical; randomized; registry:outcomes
72	A4 vs A1	md	-11.5 percent		-12.4 to -10.6		hypothetical; randomized; age:<65; R0001832:Table 2
72	A4	percent change	-13.0 percent		-15.7 to -10.4	46	hypothetical; randomized; age:>=65; R0001832:Table 2
72	A4 vs A1	md	-11.4 percent		-14.6 to -8.3		hypothetical; randomized; age:>=65; R0001832:Table 2

All cause mortality (4 lines; O20)

Arm	Statistic	Events / N	Detail
A1	events	1 / 948	not stated; safety; registry:adverse_events
A2	events	1 / 723	not stated; safety; registry:adverse_events
A3	events	1 / 724	not stated; safety; registry:adverse_events
A4	events	0 / 728	not stated; safety; registry:adverse_events

Serious adverse events (4 lines; O25)

Arm	Statistic	Events / N	Detail
A1	events	46 / 948	not stated; safety; registry:adverse_events
A2	events	40 / 723	not stated; safety; registry:adverse_events
A3	events	39 / 724	not stated; safety; registry:adverse_events
A4	events	28 / 728	not stated; safety; registry:adverse_events

Discontinuation due to adverse events (4 lines; O26)

Arm	Statistic	Events / N	Detail
A1	events	10 / 949	not stated; randomized; registry:flow
A2	events	8 / 723	not stated; randomized; registry:flow
A3	events	13 / 725	not stated; randomized; registry:flow
A4	events	16 / 730	not stated; randomized; registry:flow

Nausea (4 lines; O27A)

Arm	Statistic	Events / N	Detail
A1	events	99 / 948	not stated; safety; registry:adverse_events
A2	events	209 / 723	not stated; safety; registry:adverse_events
A3	events	260 / 724	not stated; safety; registry:adverse_events
A4	events	245 / 728	not stated; safety; registry:adverse_events

Vomiting (8 lines; O27B)

Arm	Statistic	Events / N	Detail
A1	events	33 / 948	not stated; safety; registry:adverse_events
A1	events	0 / 948	not stated; safety; registry:adverse_events
A2	events	94 / 723	not stated; safety; registry:adverse_events
A2	events	0 / 723	not stated; safety; registry:adverse_events
A3	events	155 / 724	not stated; safety; registry:adverse_events
A3	events	1 / 724	not stated; safety; registry:adverse_events
A4	events	175 / 728	not stated; safety; registry:adverse_events
A4	events	0 / 728	not stated; safety; registry:adverse_events

Diarrhea (4 lines; O27C)

Arm	Statistic	Events / N	Detail
A1	events	91 / 948	not stated; safety; registry:adverse_events
A2	events	152 / 723	not stated; safety; registry:adverse_events
A3	events	165 / 724	not stated; safety; registry:adverse_events
A4	events	168 / 728	not stated; safety; registry:adverse_events

Constipation (8 lines; O27D)

Arm	Statistic	Events / N	Detail
A1	events	0 / 948	not stated; safety; registry:adverse_events
A1	events	88 / 948	not stated; safety; registry:adverse_events
A2	events	1 / 723	not stated; safety; registry:adverse_events
A2	events	156 / 723	not stated; safety; registry:adverse_events
A3	events	0 / 724	not stated; safety; registry:adverse_events
A3	events	216 / 724	not stated; safety; registry:adverse_events
A4	events	0 / 728	not stated; safety; registry:adverse_events
A4	events	185 / 728	not stated; safety; registry:adverse_events

Gallbladder and biliary disease (20 lines; O28)

Arm	Statistic	Events / N	Detail
A1	events	1 / 948	not stated; safety; Cholecystitis chronic; registry:adverse_events
A1	events	0 / 948	not stated; safety; Biliary colic; registry:adverse_events
A1	events	1 / 948	not stated; safety; Acute cholecystitis necrotic; registry:adverse_events
A1	events	1 / 948	not stated; safety; Cholecystitis acute; registry:adverse_events
A1	events	1 / 948	not stated; safety; Cholelithiasis; registry:adverse_events
A2	events	0 / 723	not stated; safety; Biliary colic; registry:adverse_events
A2	events	0 / 723	not stated; safety; Acute cholecystitis necrotic; registry:adverse_events
A2	events	1 / 723	not stated; safety; Cholecystitis acute; registry:adverse_events
A2	events	1 / 723	not stated; safety; Cholelithiasis; registry:adverse_events
A2	events	0 / 723	not stated; safety; Cholecystitis chronic; registry:adverse_events
A3	events	2 / 724	not stated; safety; Cholecystitis chronic; registry:adverse_events
A3	events	0 / 724	not stated; safety; Acute cholecystitis necrotic; registry:adverse_events
A3	events	1 / 724	not stated; safety; Cholecystitis acute; registry:adverse_events
A3	events	0 / 724	not stated; safety; Biliary colic; registry:adverse_events
A3	events	1 / 724	not stated; safety; Cholelithiasis; registry:adverse_events
A4	events	0 / 728	not stated; safety; Acute cholecystitis necrotic; registry:adverse_events
A4	events	1 / 728	not stated; safety; Biliary colic; registry:adverse_events
A4	events	3 / 728	not stated; safety; Cholecystitis acute; registry:adverse_events
A4	events	0 / 728	not stated; safety; Cholecystitis chronic; registry:adverse_events
A4	events	2 / 728	not stated; safety; Cholelithiasis; registry:adverse_events

Acute pancreatitis (12 lines; O29)

Arm	Statistic	Events / N	Detail
A1	events	0 / 948	not stated; safety; Obstructive pancreatitis; registry:adverse_events
A1	events	0 / 948	not stated; safety; Pancreatitis acute; registry:adverse_events
A1	events	0 / 948	not stated; safety; Pancreatitis relapsing; registry:adverse_events
A2	events	0 / 723	not stated; safety; Obstructive pancreatitis; registry:adverse_events
A2	events	0 / 723	not stated; safety; Pancreatitis acute; registry:adverse_events
A2	events	0 / 723	not stated; safety; Pancreatitis relapsing; registry:adverse_events
A3	events	2 / 724	not stated; safety; Obstructive pancreatitis; registry:adverse_events
A3	events	0 / 724	not stated; safety; Pancreatitis acute; registry:adverse_events
A3	events	0 / 724	not stated; safety; Pancreatitis relapsing; registry:adverse_events
A4	events	0 / 728	not stated; safety; Obstructive pancreatitis; registry:adverse_events
A4	events	2 / 728	not stated; safety; Pancreatitis acute; registry:adverse_events
A4	events	1 / 728	not stated; safety; Pancreatitis relapsing; registry:adverse_events

Thyroid cancer (any) (4 lines; O32B)

Arm	Statistic	Events / N	Detail
A1	events	2 / 948	not stated; safety; Papillary thyroid cancer; registry:adverse_events
A2	events	0 / 723	not stated; safety; Papillary thyroid cancer; registry:adverse_events
A3	events	0 / 724	not stated; safety; Papillary thyroid cancer; registry:adverse_events
A4	events	0 / 728	not stated; safety; Papillary thyroid cancer; registry:adverse_events

Suicidal ideation or behavior (4 lines; O35A)

Arm	Statistic	Events / N	Detail
A1	events	1 / 948	not stated; safety; Depression suicidal; registry:adverse_events
A2	events	0 / 723	not stated; safety; Depression suicidal; registry:adverse_events
A3	events	0 / 724	not stated; safety; Depression suicidal; registry:adverse_events
A4	events	0 / 728	not stated; safety; Depression suicidal; registry:adverse_events

Pancreatic cancer (4 lines; O38)

Arm	Statistic	Events / N	Detail
A1	events	0 / 948	not stated; safety; Adenocarcinoma pancreas; registry:adverse_events
A2	events	0 / 723	not stated; safety; Adenocarcinoma pancreas; registry:adverse_events
A3	events	0 / 724	not stated; safety; Adenocarcinoma pancreas; registry:adverse_events
A4	events	1 / 728	not stated; safety; Adenocarcinoma pancreas; registry:adverse_events