You are now leaving the Lilly Medical website
The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to Lilly Medical
If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
Foundayo ™ (orforglipron) tablet
0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
Which patients are appropriate for initiation of Foundayo™ (orforglipron) for weight management?
Orforglipron is indicated in combination with a reduced-calorie diet and increased physical activity to reduce weight and maintain weight reduction in adults with obesity or overweight. Patient populations from phase 3 studies are described.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Who Should Orforglipron Be Initiated In?
- Who Was Enrolled in the Orforglipron Weight Management Studies?
- References
Who Should Orforglipron Be Initiated In?
Orforglipron is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with
- obesity, or
- overweight in the presence of at least one weight-related comorbid condition.1
The decision to prescribe orforglipron should be made by the treating physician, based on their clinical judgment and the individual needs of the patient.
This medical response provides information on the participant populations enrolled in the orforglipron phase 3 studies in weight management, and no information is available on baseline characteristics that would predict efficacy and tolerability of orforglipron.
Who Was Enrolled in the Orforglipron Weight Management Studies?
The efficacy and safety of orforglipron in adults with obesity or overweight were evaluated in 2 randomized, double-blind, placebo-controlled trials, including
- ATTAIN-1 in adults with obesity or overweight with at least one weight-related comorbidity excluding type 2 diabetes (T2D), and
- ATTAIN-2 in adults with obesity or overweight with T2D.2,3
ATTAIN-1 and ATTAIN-2 had a treatment duration of 72 weeks and compared an investigational orforglipron capsule formulation with placebo.2,3
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.1-4
In both studies, all participants received lifestyle interventions, including guidance on diet and physical activity.2,3
Patient Population
In ATTAIN-1 and ATTAIN-2, participants were included if they
- were ≥18 years old, and
- had a history of at least one self-reported unsuccessful dietary weight loss effort.2,3,5
In ATTAIN-1, additional inclusion criteria included a
- body mass index (BMI) ≥30.0 kg/m² (obesity), or
- BMI ≥27.0 kg/m² (overweight) with at least one weight-related comorbidity (including hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease).2,5
In ATTAIN-2, additional inclusion criteria included
- a BMI ≥27.0 kg/m², and
- T2D with a glycated hemoglobin (HbA1c) between ≥7% and ≤10% and stable treatment for at least 90 days prior to screening, consisting of either diet/exercise alone or up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase-4 inhibitors or glucagon-like peptide-1 receptor agonists).3,5
In ATTAIN-1 and ATTAIN-2, participants were excluded if they had type 1 diabetes, a history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes (except T2D for ATTAIN-2).2,3,5
In ATTAIN-2, additional exclusion criteria included a
- history of severe hypoglycemia or hypoglycemia unawareness, and
- current or planned treatment for diabetic retinopathy or macular edema.3,5
Participant Demographics
Across ATTAIN-1 and ATTAIN-2, baseline participant demographics were well balanced between placebo and orforglipron treatment groups. Demographics were generally similar between both studies, and overall adequately represented a broad adult age range, both sexes, and globally diverse racial and ethnic groups.5
See Table 1 for more information on baseline demographics for participants in ATTAIN-1 and ATTAIN-2
Table 1. Baseline Demographics Across ATTAIN-1 and ATTAIN-22-5
|
ATTAIN-1 |
ATTAIN-2 |
||||||
|---|---|---|---|---|---|---|---|---|
Parameter |
OFG 5.5 mg (N=723) |
OFG 9 mg (N=725) |
OFG 17.2 mg (N=730) |
PBO (N=949) |
OFG 5.5 mg (N=329) |
OFG 9 mg (N=332) |
OFG 17.2 mg (N=322) |
PBO (N=630) |
Age, yearsa |
44.9 |
45.4 |
44.9 |
45.1 |
56.8 |
56.2 |
58.1 |
56.5 |
Age group, n (%) |
||||||||
<65 years |
683 (94.5) |
674 (93.0) |
684 (93.7) |
890 (93.8) |
251 (76.3) |
247 (74.4) |
221 (68.6) |
474 (75.2) |
≥65 years |
40 (5.5) |
51 (7.0) |
46 (6.3) |
59 (6.2) |
78 (23.7) |
85 (25.6) |
101 (31.4) |
156 (24.8) |
Sex, n (%) |
||||||||
Male |
254 (35.1) |
258 (35.6) |
265 (36.3) |
341 (35.9) |
179 (54.4) |
177 (53.3) |
168 (52.2) |
332 (52.7) |
Female |
469 (64.9) |
467 (64.4) |
465 (63.7) |
608 (64.1) |
150 (45.6) |
155 (46.7) |
154 (47.8) |
298 (47.3) |
Race, n (%)b |
||||||||
American Indian or Alaska Native |
2 (0.3) |
3 (0.4) |
2 (0.3) |
4 (0.4) |
0 (0.0) |
2 (0.6) |
1 (0.3) |
2 (0.3) |
Asian |
202 (28.0) |
201 (27.7) |
214 (29.3) |
267 (28.1) |
58 (17.6) |
55 (16.6) |
54 (16.8) |
112 (17.8) |
Black or African American |
68 (9.4) |
60 (8.3) |
67 (9.2) |
72 (7.6) |
21 (6.4) |
19 (5.7) |
28 (8.7) |
37 (5.9) |
Native Hawaiian or Other Pacific Islander |
0 (0.0) |
1 (0.1) |
0 (0.0) |
2 (0.2) |
2 (0.6) |
1 (0.3) |
0 (0.0) |
3 (0.5) |
White |
408 (56.5) |
405 (55.9) |
394 (54.0) |
539 (56.8) |
238 (72.3) |
235 (70.8) |
228 (70.8) |
442 (70.2) |
Multiple |
35 (4.8) |
45 (6.2) |
47 (6.4) |
54 (5.7) |
5 (1.5) |
12 (3.6) |
6 (1.9) |
22 (3.5) |
Not Reported |
7 (1.0) |
10 (1.4) |
6 (0.8) |
11 (1.2) |
5 (1.5) |
8 (2.4) |
5 (1.6) |
12 (1.9) |
Geographic region, n (%) |
||||||||
Asia |
195 (27.0) |
194 (26.8) |
200 (27.4) |
257 (27.1) |
52 (15.8) |
50 (15.1) |
50 (15.5) |
102 (16.2) |
Australia |
NA |
NA |
NA |
NA |
18 (5.5) |
19 (5.7) |
20 (6.2) |
35 (5.6) |
Central/South America |
203 (28.1) |
203 (28.0) |
205 (28.1) |
273 (28.8) |
80 (24.1) |
79 (23.7) |
76 (23.6) |
150 (23.8) |
Europe |
125 (17.3) |
130 (17.9) |
127 (17.4) |
169 (17.8) |
92 (28.0) |
93 (28.0) |
87 (27.0) |
170 (27.0) |
North America |
200 (27.7) |
198 (27.3) |
198 (27.1) |
250 (26.3) |
90 (27.4) |
90 (27.1) |
89 (27.6) |
173 (27.5) |
Abbreviations: NA = not applicable; OFG = orforglipron; PBO = placebo.
ᵃ Data for age is presented as mean.
ᵇ The number of participants with nonmissing data was used as the denominator. For ATTAIN-1, N=722 for OFG 5.5 mg.
Baseline Disease-Related Characteristics
The baseline disease-related characteristics demonstrate that participants across ATTAIN-1 and ATTAIN-2 represent a broad spectrum of obesity severity as measured by BMI, cardiometabolic parameters, glycemic control, and obesity-related comorbidities.5
See Table 2 for more information on disease-related characteristics at baseline in ATTAIN-1 and ATTAIN-2.
Table 2. Disease-Related Characteristics at Baseline in ATTAIN-1 and ATTAIN-22-5
|
ATTAIN-1 |
ATTAIN-2 |
||||||
|---|---|---|---|---|---|---|---|---|
Parameterᵃ |
OFG 5.5 mg (N=723) |
OFG 9 mg (N=725) |
OFG 17.2 mg (N=730) |
PBO (N=949) |
OFG 5.5 mg (N=329) |
OFG 9 mg (N=332) |
OFG 17.2 mg (N=322) |
PBO (N=630) |
Body weight, kg |
103.2 |
102.2 |
103.1 |
103.9 |
102.3 |
102.7 |
99.8 |
101.2 |
BMI, kg/m² |
37.0 |
36.8 |
36.9 |
37.2 |
35.9 |
36.1 |
35.1 |
35.5 |
BMI group, n (%) |
||||||||
<30 |
62 (8.6) |
72 (9.9) |
68 (9.3) |
86 (9.1) |
67 (20.4) |
52 (15.7) |
83 (25.8) |
124 (19.7) |
≥30 to <35 |
263 (36.4) |
272 (37.5) |
285 (39.0) |
331 (34.9) |
108 (32.8) |
111 (33.4) |
97 (30.1) |
222 (35.2) |
≥35 to <40 |
202 (27.9) |
198 (27.3) |
183 (25.1) |
266 (28.0) |
85 (25.8) |
90 (27.1) |
83 (25.8) |
151 (24.0) |
≥40 |
196 (27.1) |
183 (25.2) |
194 (26.6) |
266 (28.0) |
69 (21.0) |
79 (23.8) |
59 (18.3) |
133 (21.1) |
Duration of obesity, yearsᵇ |
13.5 |
13.7 |
13.4 |
13.6 |
18.7 |
17.2 |
18.0 |
18.3 |
Waist circumference, cm |
112.2 |
112.0 |
112.4 |
112.8 |
116.8 |
116.2 |
114.7 |
115.0 |
HbA1c, %ᶜ |
5.6 |
5.6 |
5.6 |
5.6 |
8.0 |
8.1 |
8.1 |
8.0 |
Duration of diabetes, years |
NA |
NA |
NA |
NA |
9.3 |
7.7 |
9.1 |
8.2 |
Baseline number of AHMs, n (%) |
||||||||
None |
NA |
NA |
NA |
NA |
31 (9.4) |
35 (10.5) |
35 (10.9) |
73 (11.6) |
1 AHM |
NA |
NA |
NA |
NA |
176 (53.5) |
172 (51.8) |
146 (45.3) |
311 (49.4) |
2 AHMs |
NA |
NA |
NA |
NA |
103 (31.3) |
106 (31.9) |
121 (37.6) |
204 (32.4) |
≥3 AHMs |
NA |
NA |
NA |
NA |
19 (5.8) |
19 (5.7) |
20 (6.2) |
42 (6.7) |
Abbreviations: AHM = antihyperglycemic medication; BMI = body mass index; HbA1c = glycated hemoglobin; NA = not applicable; OFG = orforglipron; PBO = placebo.
ᵃ Data is mean or mean (SD) unless otherwise noted.
ᵇ The number of participants with nonmissing data was used as the denominator. For ATTAIN-1, N=672 for OFG 5.5 mg, N=660 for OFG 9 mg, N=663 for OFG 17.2 mg, and N=874 for PBO. For ATTAIN-2, N=250 for OFG 5.5 mg, N=276 for OFG 9 mg, N=246 for OFG 17.2 mg, and N=498 for PBO.
ᶜ The number of participants with nonmissing data was used as the denominator. For ATTAIN-1, N=722 for OFG 5.5 mg, N=724 for OFG 9 mg, and N=948 for PBO.
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- 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
- Horn DB, Ryan DH, Giljanovic Kis S, et al; ATTAIN-2 Trial Investigators.
Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind,
randomised, multicentre, placebo-controlled trial. Lancet.
2025;406(10522):2927-2944. https://doi.org/10.1016/S0140-6736(25)02165-8. - 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. 2026;28(7):5803- 5809. https://doi.org/10.1111/dom.70783
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: April 01, 2026