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Foundayo ^™ (orforglipron) tablet

0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg

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In ATTAIN-1, how did Foundayo™ (orforglipron) compare with placebo in adults with obesity or overweight without type 2 diabetes?

In ATTAIN-1, orforglipron reduced body weight by 7.5% to 11.2% at 72 weeks, compared with 2.1% with placebo (treatment-regimen estimand). The safety and tolerability of orforglipron were consistent with injectable GLP-1 RAs.

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ATTAIN-1 Overview

ATTAIN-1 was a phase 3, 72-week, double-blind, randomized, placebo-controlled trial evaluating the efficacy and safety of orforglipron as monotherapy in adults with obesity without diabetes mellitus.¹

This study was conducted with an investigational orforglipron capsule formulation compared with placebo.¹

This response presents efficacy data from the investigational orforglipron capsule formulation (1 mg, 3 mg, 6 mg, 12 mg, 24 mg, and 36 mg) shown as equivalent doses of once daily orforglipron tablets (0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg) approved in the United States.^1-3

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Study Design in ATTAIN-1

The ATTAIN-1 trial randomized 3127 participants across the United States (including Puerto Rico), Brazil, China, India, Japan, Republic of Korea, Slovakia, Spain, and Taiwan in a 3:3:3:4 ratio to receive either

orforglipron 5.5 mg
orforglipron 9 mg
orforglipron 17.2 mg, or
placebo.^1,2

During the study, orforglipron was administered daily by oral capsule without food and water restrictions.¹

Figure 1 presents an overview of the study design, including the different treatment arms and dose escalation strategy for orforglipron.

attain-1 sum.png — Figure 1. ATTAIN-1 Study Design Overview^1,2,4

Figure 1 description: ATTAIN-1 was a phase 3, 72-week, double-blind, placebo-controlled trial that randomized 3127 adults with obesity or overweight with at least one weight-related comorbidity in a 3:3:3:4 ratio to receive orforglipron (5.5 mg, 9 mg, or 17.2 mg) or placebo once daily. Orforglipron-treated participants followed a dose escalation regimen (starting at 0.8 mg, followed by 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg) every 4 weeks until the assigned dose was reached. Dose reduction was allowed if gastrointestinal symptoms persisted despite mitigations. All participants received personalized counselling throughout the study, focused on a healthy, balanced diet along with physical activity.
Abbreviations: OFG = orforglipron; PBO = placebo; QD = once daily.

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Key Inclusion and Exclusion Criteria in ATTAIN-1

Key inclusion criteria for ATTAIN-1 included

age ≥18 years
a body mass index (BMI) ≥30.0 kg/m² or ≥27.0 kg/m² with at least 1 weight-related comorbidity (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease such as ischemic cardiovascular disease or New York Heart Association Functional Class I-III heart failure), and
at least 1 self-reported unsuccessful dietary effort to lose body weight.¹

In ATTAIN-1, key exclusion criteria included a

history of type 1 diabetes, type 2 diabetes (T2D), or any other type of diabetes
weight change >5 kg (11 lbs) within 90 days prior to screening
family or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2), or
a history of chronic or acute pancreatitis.¹

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Key Primary and Secondary Endpoints in ATTAIN-1

The primary objective in ATTAIN-1 was to demonstrate that orforglipron (5.5 mg, 9 mg, 17.2 mg) is superior to placebo in percent change in body weight from baseline to week 72.^1,2

Key multiplicity-adjusted secondary endpoints measured at week 72 and compared with placebo included the

proportion of participants with body weight reduction ≥5%, ≥10%, and ≥15% for orforglipron 5.5 mg
proportion of participants with body weight reduction ≥5%, ≥10%, ≥15%, and ≥20% for orforglipron 9 mg and 17.2 mg
change from baseline in waist circumference for all orforglipron dose groups, and
change from baseline in systolic blood pressure (SBP), non-high-density lipoprotein (non-HDL) cholesterol, and triglycerides for pooled orforglipron dose groups.^1,2

A graphical testing procedure for multiple comparisons was used for testing the primary and multiplicity-adjusted secondary end points to control for the overall family-wise type I error rate at 0.05.¹

Baseline Demographics and Clinical Characteristics of Participants in ATTAIN-1

In the ATTAIN-1 study, baseline demographics and clinical characteristics of participants were consistent across all treatment groups. At baseline, participants had a mean

age of 45 years
body weight of 103.2 kg, and
body mass index (BMI) of 37.0 kg/m².¹

In the overall study population, 64.2% of participants were female.¹

At baseline, the mean glycated hemoglobin (HbA1c) was 5.6% and 36.0% of participants had prediabetes.¹

More information on baseline demographics and clinical characteristics in the ATTAIN-1 study can be found in the Appendix.

Discontinuation

A total of 2662 (85.1%) participants completed the ATTAIN-1 trial, and 2344 (75.0%) participants continued to receive study treatment throughout the 72-week treatment period.¹

The proportion of participants who discontinued treatment for any reason was between

21.9% to 24.4% in the orforglipron groups, and
29.9% in the placebo group.¹

The most common reasons were participant decision to withdraw and adverse events (AEs).¹

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Efficacy Results From ATTAIN-1

Efficacy Estimand and Treatment Regimen Estimand

Two statistical estimands, efficacy or treatment-regimen, were used to evaluate efficacy data in ATTAIN-1. Briefly, the

efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments, and
treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.¹

The treatment-regimen estimand was the primary estimand, with the efficacy estimand considered supportive. There was no adjustment for multiple comparisons between estimands, nor for any other analyses beyond the primary and key secondary objectives.¹

Primary and Secondary Endpoint Results From ATTAIN-1

In ATTAIN-1, treatment with orforglipron met the primary endpoint of superior body weight reduction compared with placebo.¹

At week 72, for the treatment-regimen estimand, mean percent change from baseline in body weight was

-7.5% with orforglipron 5.5 mg
-8.4% with orforglipron 9 mg
-11.2% with orforglipron 17.2 mg, and
-2.1% with placebo (p<.001 for all orforglipron doses vs placebo; Table 1).^1,2

Change in body weight over time in ATTAIN-1 for the efficacy estimand is presented in Figure 2.

Figure 2. Change From Baseline in Body Weight Over Time in ATTAIN-1 (Efficacy Estimand)^1,2

Figure 2 description: In ATTAIN-1, change from baseline in body weight at week 72 was -7.8%, -9.3%, and -12.4% with orforglipron 5.5 mg, 9 mg, and 17.2 mg, respectively, and -0.9% with placebo.
Notes: Data are presented as model-based estimates (95% CI), along with ETD (95% CI) between orforglipron groups and placebo based on MMRM analysis (efficacy estimand).
Efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.
 Abbreviations: ETD = estimated treatment difference; MMRM = mixed model for repeated measures; OFG = orforglipron; PBO = placebo.

As presented in Table 1, all weight-related key secondary endpoints were met in the ATTAIN-1 trial.¹

Additionally, as described in Table 2, for the treatment-regimen estimand at week 72, significant improvements were observed for the key secondary cardiometabolic risk factor endpoint of change from baseline in waist circumference (p<.001 for all orforglipron doses vs placebo).¹

See Table 2 for changes from baseline in SBP, non-HDL cholesterol, and triglycerides at week 72 in ATTAIN-1 for the treatment-regimen estimand.

Table 1. Primary and Key Secondary Efficacy Endpoints in ATTAIN-1 (Treatment-Regimen Estimand)^1,2
Parameter^a	OFG 5.5 mg (N=723)	OFG 9 mg (N=725)	OFG 17.2 mg (N=730)	PBO (N=949)
Primary endpoint
Change in body weight from baseline to week 72, %	-7.5	-8.4	-11.2	-2.1
Difference vs. placebo, %	-5.5 (-6.5, -4.5)*	-6.3 (-7.3, -5.4)*	-9.1 (-10.1, -8.1)*	NA
Key secondary endpoints
Proportion of participants with weight reduction threshold at week 72, %
≥5%	60.6*	63.5*	71.8*	26.8
≥10%	33.3*	40.0*	54.6*	12.9
≥15%	15.1*	20.3*	36.0*	5.9
≥20%^b	6.4	9.0*	18.4*	2.8

Abbreviations: ANCOVA = analysis of covariance; NA = not applicable; OFG = orforglipron; PBO = placebo.
Notes: *p<.001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.
 ^a Data are model-based estimates (95% CI) assessed with the use of ANCOVA (treatment-regimen estimand). The CIs have not been adjusted for multiplicity and should not be used for hypothesis testing. For the proportion of participants with body weight reduction thresholds, data are presented as model-based estimate from logistic regression. Percentages were calculated by combining the percentages of participants who met the target in imputed data sets with the use of Rubin’s rules.
^b The proportion of participants with weight reduction threshold ≥20% at week 72 for orforglipron 5.5 mg vs placebo was not a key secondary endpoint in ATTAIN-1 and thus not controlled for type 1 error. P value was not included.

Table 2. Secondary Cardiometabolic Risk Factor Efficacy Endpoints in ATTAIN-1 (Treatment-Regimen Estimand)^1,2
Parameter^a	OFG 5.5 mg (N=723)	OFG 9 mg (N=725)	OFG 17.2 mg (N=730)	Pooled OFG^b (N=2178)	PBO (N=949)
Change in waist circumference, cm	-7.1*	-8.2*	-10.0*	NA	-3.1
Change in SBP, mmHg^c	-5.7	-5.1	-6.3	-5.7*	-1.4
Change in non-HDL cholesterol, %^c	-5.4	-7.0	-7.7	-6.7*	-1.9
Change in triglycerides, %^c	-10.4	-13.5	-20.2	-14.8*	-3.8

Abbreviations: ANCOVA = analysis of covariance; HDL = high-density lipoprotein; NA = not applicable; OFG = orforglipron; PBO = placebo; SBP = systolic blood pressure.
Notes: *p<.001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments. 
^a Data are model-based estimates assessed with the use of ANCOVA (treatment-regimen estimand). Lipid measures were log-transformed before fitting the analysis-of-covariance model, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
^b The pooled orforglipron group includes patients in the 5.5 mg, 9 mg, and 17.2 mg orforglipron groups.
^c Change from baseline to week 72 in SBP, non-HDL cholesterol, and triglyceride for orforglipron 5.5 mg, 9 mg, or 17.2 mg vs placebo were not key secondary endpoints. These endpoints were not adjusted for type 1 error and p values were not included for these endpoints.

Refer to the Appendix for primary, key secondary, and secondary cardiometabolic risk factor data based on the efficacy estimand.

Additional Efficacy Findings From ATTAIN-1

For the treatment-regimen estimand, at week 72, mean decrease in diastolic blood pressure was

-2.4 mm Hg in the pooled orforglipron group, and
-1.4 mm Hg in the placebo group.¹

Change in total cholesterol at week 72, for the treatment-regimen estimand, was

-4.1% in the pooled orforglipron group, and
-2.0% in the placebo group.¹

At week 72, using the treatment-regimen estimand, change in high-sensitivity C-reactive protein (hsCRP) was

-33.3% with orforglipron 5.5 mg
-38.6% with orforglipron 9 mg
-43.6% with orforglipron 17.2 mg, and
-14.7% with placebo.^1,2

Additionally, at week 72, the proportion of participants with prediabetes at baseline who had normoglycemic levels was

74.6% to 83.7% of orforglipron-treated participants, and
44.6% of placebo-treated participants.¹

Refer to the Appendix for additional efficacy findings based on the efficacy estimand.

Changes in Body Composition in ATTAIN-1

In ATTAIN-1, changes in body composition from baseline to week 72 were assessed in a subset of participants using dual-energy X-ray absorptiometry (DXA).¹

Refer to Table 3 for treatment-regimen estimand data for participants who completed DXA scans, including mean percent change in

total body fat mass
lean mass, and
visceral fat mass.

Table 3. Change in Body Composition at Week 72 in Participants Undergoing DXA (Treatment-Regimen Estimand)^1,2
Parameter^a	OFG 5.5 mg	OFG 9 mg	OFG 17.2 mg	PBO
Total fat mass, (%)	-12.0	-9.4	-20.0	-1.7
Total lean mass, (%)	-3.7	-3.2	-6.6	0.3
Visceral fat mass, (%)	-16.3	-12.6	-28.2	7.4

Abbreviations: DXA = dual-energy X-ray absorptiometry; OFG = orforglipron; PBO = placebo.
Notes: Enrolled n=171; completers with both baseline and week 72 DXA n=140.
^a Data are model-based estimates.

Refer to the Appendix for changes in body composition data based on the efficacy estimand.

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Safety Results From ATTAIN-1

The overall safety profile of orforglipron in ATTAIN-1 was consistent with the established GLP-1 receptor agonist class.¹

The most commonly reported AEs were gastrointestinal-related. These events were generally mild to moderate in severity and started mainly during dose escalation in orforglipron-treated participants.¹

The proportion of participants that discontinued due to gastrointestinal AEs were

3.5% to 7.0% of orforglipron-treated participants, and
0.4% of placebo participants.¹

An overview of AEs and AEs that occurred in ≥5% of participants are presented in Table 4 and Table 5, respectively.

Table 4. Overview of Adverse Events^1,2
Adverse Event^a	OFG 5.5 mg (N=723)	OFG 9 mg (N=724)	OFG 17.2 mg (N=728)	PBO (N=948)	Overall (N=3123)
Any AE emerging during treatment	603 (83.4)	627 (86.6)	620 (85.2)	763 (80.5)	2613 (83.7)
Serious AEs	40 (5.5)	39 (5.4)	28 (3.8)	46 (4.9)	153 (4.9)
Deaths^b	1 (0.1)	1 (0.1)	0 (0.0)	1 (0.1)	3 (0.1)
AEs leading to discontinuation of study treatment	38 (5.3)	57 (7.9)	75 (10.3)	26 (2.7)	196 (6.3)
GI disorders leading to discontinuation of study treatment	25 (3.5)	38 (5.2)	51 (7.0)	4 (0.4)	118 (3.8)

Abbreviations: AE = adverse event; GI gastrointestinal; OFG = orforglipron; PBO = placebo.
^a Data are n (%) in safety population.
^b Causes of death were reported as follows: undetermined for the participant in the 5.5 mg group orforglipron group, metastatic ovarian cancer in the participant in the 9 mg orforglipron group, and pulmonary embolism for the participant in the placebo group. Deaths were also counted as serious AEs and discontinuation of the trial regimen owing to AEs.

Table 5. Adverse Events Occurring in ≥5% of Participants in the ATTAIN-1 Study^1,2
Adverse Event^a	OFG 5.5 mg (N=723)	OFG 9 mg (N=724)	OFG 17.2 mg (N=728)	PBO (N=948)	Overall (N=3123)
Nausea	209 (28.9)	260 (35.9)	245 (33.7)	99 (10.4)	813 (26.0)
Constipation	157 (21.7)	216 (29.8)	185 (25.4)	88 (9.3)	646 (20.7)
Diarrhea	152 (21.0)	165 (22.8)	168 (23.1)	91 (9.6)	576 (18.4)
Vomiting	94 (13.0)	155 (21.4)	175 (24.0)	33 (3.5)	457 (14.6)
Dyspepsia	95 (13.1)	117 (16.2)	103 (14.1)	47 (5.0)	362 (11.6)
URTI	75 (10.4)	75 (10.4)	64 (8.8)	103 (10.9)	317 (10.2)
Headache	62 (8.6)	75 (10.4)	71 (9.8)	71 (7.5)	279 (8.9)
Influenza	68 (9.4)	58 (8.0)	44 (6.0)	73 (7.7)	243 (7.8)
Nasopharyngitis	55 (7.6)	61 (8.4)	47 (6.5)	74 (7.8)	237 (7.6)
Abdominal distension	52 (7.2)	68 (9.4)	62 (8.5)	32 (3.4)	214 (6.9)
COVID-19	44 (6.1)	52 (7.2)	54 (7.4)	50 (5.3)	200 (6.4)
Decreased appetite	42 (5.8)	61 (8.4)	53 (7.3)	30 (3.2)	186 (6.0)
Abdominal pain upper	44 (6.1)	45 (6.2)	57 (7.8)	33 (3.5)	179 (5.7)
Gastroenteritis	45 (6.2)	42 (5.8)	50 (6.9)	36 (3.8)	173 (5.5)
Back pain	34 (4.7)	39 (5.4)	45 (6.2)	54 (5.7)	172 (5.5)
Arthralgia	34 (4.7)	37 (5.1)	35 (4.8)	60 (6.3)	166 (5.3)
Abdominal pain	38 (5.3)	50 (6.9)	44 (6.0)	25 (2.6)	157 (5.0)
Anxiety	37 (5.1)	29 (4.0)	27 (3.7)	64 (6.8)	157 (5.0)
Eructation	44 (6.1)	43 (5.9)	55 (7.6)	10 (1.1)	152 (4.9)
GERD	40 (5.5)	42 (5.8)	46 (6.3)	21 (2.2)	149 (4.8)
Flatulence	31 (4.3)	40 (5.5)	41 (5.6)	17 (1.8)	129 (4.1)
Alopecia	30 (4.1)	36 (5.0)	39 (5.4)	23 (2.4)	128 (4.1)
Fatigue	26 (3.6)	25 (3.5)	37 (5.1)	15 (1.6)	103 (3.3)

Abbreviations: GERD = gastroesophageal reflux disease; OFG = orforglipron; PBO = placebo; URTI = upper respiratory tract infection.
^a Data are n (%) in safety population.

Five cases of adjudication-confirmed mild pancreatitis were reported in participants receiving orforglipron (1 participant in the orforglipron 5.5 mg group and 2 participants each from the 9 mg and 17.2 mg orforglipron dose groups) with none reporting complications.^1,2

A total of 8 participants (7 orforglipron-treated participants and 1 placebo-treated participant) experienced transaminase elevations ≥10x upper limit of normal (ULN). For all 7 orforglipron participants, alternative causes were identified.¹

Two participants in the orforglipron groups had elevated total bilirubin >2x ULN with ALT elevation >3x ULN. Both cases had alternative causes and were not associated with drug-induced liver injury.¹

There were no cases of medullary thyroid cancer.¹

At week 72, mean pulse rate increased by

4.3 to 5.3 beats per minute across orforglipron doses, and
0.8 beats per minute with placebo.¹

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References

The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).

Wharton S, Aronne LJ, Stefanski A, et al; ATTAIN-1 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist for obesity treatment. N Engl J Med. 2025;393(18):1796-1806. https://doi.org/10.1056/NEJMoa2511774
Ma X, Li YG, Raha S, et al. Pharmacokinetic bioequivalence of orforglipron tablets and capsules in healthy participants with obesity or overweight. Diabetes Obes Metab. Published online April 17, 2026. https://doi.org/10.1111/dom.70783
Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Lilly's oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs in first of two pivotal phase 3 trials in adults with obesity. Press release. Eli Lilly and Company; August 7, 2025. Accessed August 7, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-delivers-weight-loss-average-273
Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Appendix

Baseline Demographics and Clinical Characteristics

Table 6. Baseline Demographics and Clinical Characteristics of Participants in the ATTAIN-1 Study^1,2
Parameter^a	OFG 5.5 mg (N=723)	OFG 9 mg (N=725)	OFG 17.2 mg (N=730)	PBO (N=949)
Age, years	44.9 ± 12.1	45.4 ± 12.6	44.9 ± 11.9	45.1 ± 11.9
Female, n (%)	469 (64.9)	467 (64.4)	465 (63.7)	608 (64.1)
Race or ethnic group^b, n (%)
American Indian or Alaska Native	2 (0.3)	3 (0.4)	2 (0.3)	4 (0.4)
Asian	202 (28.3)	201 (28.1)	214 (29.6)	267 (28.5)
Black or African American	68 (9.5)	60 (8.4)	67 (9.3)	72 (7.7)
White	408 (57.1)	405 (56.6)	394 (54.4)	539 (57.5)
Native Hawaiian or other Pacific Islander	0 (0.0)	1 (0.1)	0 (0.0)	2 (0.2)
Multiple	35 (4.9)	45 (6.3)	47 (6.5)	54 (5.8)
Hispanic or Latino, n (%)	273 (37.8)	275 (37.9)	258 (35.3)	369 (38.9)
Body weight, kg	103.2 ± 21.7	102.2 ± 21.6	103.1 ± 23.2	103.9 ± 22.0
BMI^c, kg/m²	37.0 ± 6.5	36.7 ± 6.5	36.9 ± 6.7	37.1 ± 6.3
BMI category, n (%)
<30	62 (8.6)	72 (9.9)	68 (9.3)	86 (9.1)
≥30 to <35	263 (36.4)	272 (37.5)	285 (39.0)	331 (34.9)
≥35 to <40	202 (27.9)	198 (27.3)	183 (25.1)	266 (28.0)
≥40	196 (27.1)	183 (25.2)	194 (26.6)	266 (28.0)
Waist circumference, cm	112.2 ± 14.1	112.0 ± 14.2	112.4 ± 15.3	112.8 ± 14.5
Blood pressure, mm Hg
Systolic	125.4 ± 14.1	125.1 ± 13.7	125.8 ± 15.9	125.8 ± 14.5
Diastolic	81.0 ± 9.3	81.2 ± 9.4	80.9 ± 10.1	81.8 ± 9.9
Lipid parameters, mg/dL
Total cholesterol	196.2 (37.6)	195.0 (39.0)	196.3 (39.5)	196.5 (39.5)
HDL cholesterol	49.6 (12.5)	50.1 (12.4)	48.5 (12.6)	49.3 (12.4)
LDL cholesterol	119.6 (32.2)	118.3 (34.1)	119.4 (33.6)	119.0 (33.6)
Non-HDL cholesterol	146.4 (36.1)	144.6 (38.0)	147.5 (38.7)	147.0 (38.1)
VLDL cholesterol	26.1 (11.8)	25.9 (11.7)	27.3 (13.2)	27.3 (12.9)
Triglycerides	135.4 (72.5)	133.5 (75.8)	142.8 (89.1)	142.4 (91.9)

Abbreviations: BMI = body mass index; HDL = high-density lipoprotein; LDL = low-density lipoprotein; VLDL = very-low-density lipoprotein; OFG = orforglipron; PBO = placebo.
^a Data are mean ± SD, unless otherwise noted.
^b Race or ethnic group was reported by participants.
^c Body-mass index is the weight in kilograms divided by the square of the height in meters.

Table 7. Additional Clinical Characteristics and Comorbidities of Participants From ATTAIN-1^1,2
Parameter	OFG 5.5 mg (N=723)	OFG 9 mg (N=725)	OFG 17.2 mg (N=730)	PBO (N=949)
Clinical Characteristics
eGFR^a, mL/min/1.73 m²	93.1 ± 18.7	92.5 ± 18.7	92.8 ± 18.4	92.4 ± 18.5
Prediabetes, n (%)	258 (35.7)	260 (35.9)	265 (36.3)	344 (36.2)
HbA1c, %	5.6 ± 0.4	5.6 ± 0.3	5.6 ± 0.3	5.6 ± 0.3
Fasting glucose, mg/dL	92.6 ± 10.0	92.1 ± 10.0	93.0 ± 10.5	92.4 ± 10.0
Fasting insulin, mIU/L	19.1 ± 13.9	18.5 ± 12.4	19.0 ± 12.3	19.0 ± 13.6
hsCRP, mg/L	5.6 ± 6.9	5.7 ± 7.6	5.5 ± 7.1	5.9 ± 7.9
Duration of obesity, years	13.5 ± 11.1	13.7 ± 10.6	13.4 ± 11.1	13.6 ± 10.9
Pulse, beats/min	73.0 ± 10.3	73.0 ± 9.9	73.5 ± 10.8	73.7 ± 10.1
Comorbidities^b, n (%)
Hypertension	294 (40.7)	276 (38.1)	288 (39.5)	378 (39.8)
Dyslipidemia	278 (38.5)	282 (38.9)	284 (38.9)	386 (40.7)
Coronary artery disease	11 (1.5)	13 (1.8)	11 (1.5)	9 (0.9)
Cerebrovascular disease	7 (1.0)	15 (2.1)	13 (1.8)	12 (1.3)
Renal disease	25 (3.5)	23 (3.2)	20 (2.7)	24 (2.5)
Female reproductive disorders^c	64 (13.6)	65 (13.9)	70 (15.1)	82 (13.5)
Dysmenorrhea/menstrual cycle abnormal/infertility	59 (12.6)	54 (11.6)	63 (13.5)	71 (11.7)
PCOS	12 (2.6)	22 (4.7)	18 (3.9)	21 (3.5)
Obstructive sleep apnea	76 (10.5)	67 (9.2)	92 (12.6)	109 (11.5)
Osteoarthritis	89 (12.3)	85 (11.7)	78 (10.7)	112 (11.8)
Anxiety/depression	117 (16.2)	104 (14.3)	111 (15.2)	161 (17.0)
MASLD	142 (19.6)	154 (21.2)	147 (20.1)	195 (20.5)
Asthma or COPD	54 (7.5)	57 (7.9)	63 (8.6)	68 (7.2)
Gout or hyperuricemia	77 (10.7)	79 (10.9)	83 (11.4)	90 (9.5)

Abbreviations: CKD-EPI = Chronic Kidney Disease Epidemiology Collaboration; COPD = chronic obstructive pulmonary disease; eGFR = estimated glomerular filtration rate; HbA1c = glycated hemoglobin; hsCRP = high-sensitivity C-reactive protein; MASLD = metabolic dysfunction-associated steatotic liver disease; OFG = orforglipron; PBO = placebo; PCOS = polycystic ovary syndrome.
^a The eGFR was calculated according to the serum cystatin C-based CKD-EPI equation.
^b Comorbidities were assessed through a review of medical history.
^c Percentage is based on total number of female participants in the respective treatment group.

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Primary and Secondary Endpoint Results From ATTAIN-1 (Efficacy Estimand)

Table 8. Primary and Key Secondary Efficacy Endpoints in ATTAIN-1 (Efficacy Estimand)^1,2,5
Parameter^a	OFG 5.5 mg (N=723)	OFG 9 mg (N=725)	OFG 17.2 mg (N=730)	PBO (N=949)
Primary Endpoint
Change in body weight from baseline to week 72, %	-7.8	-9.3	-12.4	-0.9
Difference vs. PBO, %	-6.9 (-7.7, -6.2)*	-8.4 (-9.3, -7.6)*	-11.5 (-12.3, -10.6)*	NA
Key secondary endpoints
Proportion of participants with weight reduction threshold at week 72, %
≥5%	63.8*	69.3*	77.1*	22.1
≥10%	35.9*	45.1*	59.6*	8.6
≥15%	16.5*	24.0*	39.6*	3.6
≥20%^b	7.2	11.4*	20.1*	1.6

Abbreviations: MMRM = mixed model for repeated measures; NA = not applicable; OFG = orforglipron; PBO = placebo.
Notes: *p<.001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
Efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.
^a Data are model-based estimates (95% CI) from MMRM (efficacy estimand). The CIs have not been adjusted for multiplicity and should not be used for hypothesis testing. For the proportion of participants with body weight reduction thresholds, data are presented as model-based estimate from logistic regression. Percentages were calculated by combining the percentages of participants who met the target in imputed data sets with the use of Rubin's rules.
^b The proportion of participants with weight reduction threshold ≥20% at week 72 for orforglipron 5.5 mg vs placebo was not a key secondary endpoint in ATTAIN-1 and thus not controlled for type 1 error. P value was not included.

Table 9. Secondary Cardiometabolic Risk Factor Efficacy Endpoints in ATTAIN-1 (Efficacy Estimand)^1,2,5
Parameter^a	OFG 5.5 mg (N=723)	OFG 9 mg (N=725)	OFG 17.2 mg (N=730)	Pooled OFG^b (N=2178)	PBO (N=949)
Change in waist circumference, cm	-7.5*	-9.0*	-11.1*	-NA	-2.1
Change in SBP, mmHg^c	-5.8	-5.9	-6.7	-6.1*	-0.8
Change in non-HDL cholesterol, %^c	-5.9	-8.3	-8.5	-7.6*	-1.4
Change in triglycerides, %^c	-12.1	-15.2	-21.6	-16.4*	-4.8

Abbreviations: HDL = high-density lipoprotein; MMRM = mixed model for repeated measures; NA = not applicable; OFG = orforglipron; PBO = placebo; SBP = systolic blood pressure.
Notes:Efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.
^a Data are model-based estimates (95% CI) from MMRM (efficacy estimand). Lipid measures were log-transformed before fitting the analysis-of-covariance model, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
^b The pooled orforglipron group includes patients in the 5.5 mg, 9 mg, and 17.2 mg orforglipron groups.
^c Change from baseline to week 72 in SBP, non-HDL cholesterol, and triglyceride for orforglipron 5.5 mg, 9 mg, or 17.2 mg vs placebo were not key secondary endpoints. These endpoints were not adjusted for type 1 error and p values were not included for these endpoints.

Changes in Body Composition in ATTAIN-1 (Efficacy Estimand)

Table 10. Change in Body Composition at Week 72 in Participants Undergoing DXA (Efficacy Estimand)^1,2
Parameter^a	OFG 5.5 mg	OFG 9 mg	OFG 17.2 mg	PBO
Total body fat mass, %	-14.8	-11.1	-25.7	-1.2
Total lean mass, %	-4.9	-4.1	-8.2	0.8
Visceral fat mass, %	-20.3	-16.0	-34.3	7.3

Abbreviations: DXA = dual-energy X-ray absorptiometry; OFG = orforglipron; PBO = placebo.
Note: Enrolled n=171; completers with both baseline and week 72 DXA n=140.
^a Data are model-based estimates.

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Date of Last Review: April 01, 2026

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Foundayo ™ (orforglipron) tablet

0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg

In ATTAIN-1, how did Foundayo™ (orforglipron) compare with placebo in adults with obesity or overweight without type 2 diabetes?

In ATTAIN-1, orforglipron reduced body weight by 7.5% to 11.2% at 72 weeks, compared with 2.1% with placebo (treatment-regimen estimand). The safety and tolerability of orforglipron were consistent with injectable GLP-1 RAs.

Content Overview

ATTAIN-1 Overview

Study Design in ATTAIN-1

Key Inclusion and Exclusion Criteria in ATTAIN-1

Key Primary and Secondary Endpoints in ATTAIN-1

Baseline Demographics and Clinical Characteristics of Participants in ATTAIN-1

Discontinuation

Efficacy Results From ATTAIN-1

Efficacy Estimand and Treatment Regimen Estimand

Primary and Secondary Endpoint Results From ATTAIN-1

Additional Efficacy Findings From ATTAIN-1

Changes in Body Composition in ATTAIN-1

Safety Results From ATTAIN-1

References

Appendix

Baseline Demographics and Clinical Characteristics

Primary and Secondary Endpoint Results From ATTAIN-1 (Efficacy Estimand)

Changes in Body Composition in ATTAIN-1 (Efficacy Estimand)

Foundayo ^™ (orforglipron) tablet