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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.

What Foundayo™ (orforglipron) clinical trials are being conducted in people with obesity or overweight?

The orforglipron clinical trial program evaluates the efficacy and safety of orforglipron in adult and pediatric participants with obesity or overweight with or without comorbidities, respectively.

US_cFAQ_OFG020B_ATTAIN_OBESITY_CLINICAL_TRIALS_WM

en-US

See important safety information, including boxed warning, in the attached prescribing information.

Orforglipron Clinical Trial Program in Participants With Obesity or Overweight

Orforglipron is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated in combination with a reduced-calorie diet and 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

Orforglipron Clinical Trials in Adult Participants With Obesity or Overweight

The ATTAIN clinical trial program is currently assessing the efficacy and safety of orforglipron in participants with obesity or overweight. Three studies, within the ATTAIN program, focused on the treatment of obesity with or without T2D and include ATTAIN-1, ATTAIN-2, and ATTAIN-J.2-4

Additional studies are being conducted targeting specific obesity-related complications and special populations, including adult individuals with

obstructive sleep apnea
hypertension
osteoarthritis pain
peripheral artery disease, and
stress urinary incontinence.5-9

ATTAIN-Outcomes is also investigating the effect of orforglipron on the incidence of major adverse cardiovascular outcomes (MACE) in participants with atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD).10

ATTAIN-MAINTAIN evaluated orforglipron as a maintenance phase following injectable GLP-1 RA therapy.11

Refer to Overview of the Orforglipron Phase 3 Clinical Trial Program in Adults With Obesity or Overweight for more information on the orforglipron clinical trial program conducted with an investigational orforglipron capsule formulation at doses of 1 mg, 3 mg, 6 mg, 12 mg, 24 mg, and 36 mg.2,3

In this response, the investigational orforglipron capsule formulation is referred to here as orforglipron and presented as equivalent once-daily tablet dosages (0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg) approved in the United States.1

Overview of the Orforglipron Phase 3 Clinical Trial Program in Adults With Obesity or Overweight
Trial and Target Population	Key Inclusion Criteria	Orforglipron Groups	Comparator	Primary Endpoint(s)	Primary Timepoint
Obesity Studies
ATTAIN-11,2 in People With Obesity or Overweight NCT05869903 Complete	BMI ≥30 kg/m², or BMI ≥27 kg/m² with ≥1 weight-related comorbidity without T2Da	Oral Once daily 5.5 mg, 9 mg, or 17.2 mg doses	PBO	Percent CFB in BW	72 weeks
ATTAIN-21,3 in People With Obesity or Overweight and T2D NCT05872620 Complete	BMI ≥27 kg/m² T2D	Oral Once daily 5.5 mg, 9 mg, or 17.2 mg doses	PBO	Percent CFB in BW	72 weeks
ATTAIN-J4 in Japanese People With Obesity NCT05931380 Complete	BMI ≥27 kg/m²and <35 kg/m² and at least 2 obesity-related health problemsb BMI ≥35 kg/m² and at least 1 obesity-related health problemb	Administered PO	PBO	Percent CFB in BW	72 weeks
Additional Studies/Indications
ATTAIN-MAINTAIN1,11 in People With Obesity or Overweight NCT06584916 Complete	Have completed the SURMOUNT-5 study on study treatment12^,c	Oral Once daily 17.2 mg or MTD (14.5 mg or 17.2 mg)	PBO	Percent maintenance of BW reduction achieved in SURMOUNT-5	52 weeks
ATTAIN-OSA5^,d in People With OSA and Obesity or Overweight NCT06649045 Ongoing	BMI ≥27 kg/m² AHI ≥15 on PSG as part of the trial at screening (visit 1)e	Administered PO	PBO	CFB in AHI	52 weeks
ATTAIN-HYPERTENSTION6,13,14^,f in People With Hypertension and Obesity or Overweight NCT06948422 Ongoing	SBP ≥140 mm Hg and/or DBP ≥90 mm Hg at screening or week 0 (visit 1 or visit 3)g Untreated for HTN, or on stable antihypertensive medications ≥30 days prior to visit 1 BMI ≥25 kg/m²	Administered PO	PBO	CFB in office SBP	36 weeks
ATTAIN-OA PAIN7^,h in People With Obesity or Overweight Who Have OA NCT07153471 Ongoing	BMI ≥27 kg/m² At least 1 unsuccessful attempt to lose weight through diet OA of the knee with at least 1 of the following conditions: >50 years old, morning knee stiffness that last approximately 30 minutes, or a crackling or grinding sound/feeling in the knee	Administered PO	PBO	CFB in the WOMAC pain subscale score	72 weeks
ATTAIN-Outcomes10 in People with ASCVD and/or CKD NCT07241390 Ongoing	Have established ASCVD and/or CKD	Administered POi	PBOi	Time to first occurrence of composite endpoint of major cardiovascular eventsj	Event-driven study (approximately 5 years)
ATTAIN-PAD8 in People With PAD NCT07223593 Ongoing	Symptomatic PAD with intermittent claudication of Fontaine Stage II Have an ABI of ≤0.9	Administered PO	PBO	Percent CFB in maximum walking distance	52 weeks
RESTRAIN-SUI9^,k in Female Participants With SUI Who Have Obesity or Overweight NCT07202884 Ongoing	BMI ≥27 kg/m² A diagnosis of SUI	Administered PO	PBO	CFB in IEF	52 weeks

Abbreviations: ABI = ankle-brachial index; AHI = apnea-hypopnea index; ASCVD = atherosclerotic cardiovascular disease; BMI = body mass index; BW = body weight; CFB = change from baseline; CKD = chronic kidney disease; DBP = diastolic blood pressure; HTN = hypertension; IEF = incontinence episode frequency; MTD = maximum tolerated dose; OA = osteoarthritis; OSA = obstructive sleep apnea; PAD = peripheral artery disease; PAP = positive airway pressure; PBO = placebo; PO = orally; PSG = polysomnography; SBP = systolic blood pressure; SUI = stress urinary incontinence; T2D = type 2 diabetes; WOMAC = Western Ontario and McMaster Universities Osteoarthritis Index.

aComorbidities included hypertension, dyslipidemia, OSA, and cardiovascular disease.

bObesity-related health problems can be treated or untreated and should include either hypertension, dyslipidemia, or T2D.

cKey inclusion criteria for the SURMOUNT-5 study were a BMI ≥30 kg/m² or ≥27 kg/m² and previously diagnosed with at least 1 of the following weight-related comorbidities, hypertension, dyslipidemia, OSA, or cardiovascular disease, and have a history of at least 1 unsuccessful dietary effort to lose BW.

dATTAIN-OSA is a master protocol designed to support 2 independent studies, GZ01 and GZ02.

eThe key inclusion criteria for GZ01 includes participants who are unable or unwilling to use PAP therapy and have not used PAP for at least 4 weeks prior to screening. For GZ02, the key inclusion criteria includes participants who have been on PAP therapy for at least 3 consecutive months prior to the study start and plan to continue PAP therapy during the study.

fATTAIN-HYPERTENSION is a master protocol designed to support 2 independent studies, GZL1 and GZL2.

gIf DBP criteria alone is met, SBP must be ≥130 mm Hg.

hATTAIN-OA PAIN is a master protocol designed to support 2 independent studies, GZT1 and GZT2.

iParticipants will also receieve standard of care.

jIncludes nonfatal MI, nonfatal stroke, hospitalization or urgent visit due to HF, coronary revascularization, or all-cause death.

kRESTRAIN-SUI is a master protocol designed to support 2 independent studies, GZS1 and GZS2.

Orforglipron Clinical Trials in Pediatric Patients With Obesity or Overweight

ADVANCE is a phase 3 master protocol (PWMP) evaluating the safety and efficacy of obesity therapies for the treatment of obesity or overweight in pediatric participants.15

This PWMP establishes entry criteria for participants across the

master protocol, and
intervention-specific appendices.15

See Overview of the ADVANCE-ATTAIN Phase 3 Clinical Trial Program of Orforglipron for the Treatment of Obesity or Overweight in Pediatric Participants for more information on trials in the ADVANCE-ATTAIN orforglipron clinical trial program.

Overview of the ADVANCE-ATTAIN Phase 3 Clinical Trial Program of Orforglipron for the Treatment of Obesity or Overweight in Pediatric Participants
Trial and Target Population	Key Inclusion Criteria	Orforglipron Groups	Comparator	Primary Endpoint	Primary Timepoint
ADVANCE-ATTAIN-ADOLESCENTS16 in Adolescent Participants With Obesity, or Overweight With Related Comorbidities NCT06672939 Ongoing	Age 12-17 years History of at least 1 unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programa BMI ≥95th percentileb BMI ≥85th percentile and ≤95th percentile with at least 1 weight-related comorbidityb^,c	Administered PO	PBO	Percent CFB in BMI	72 weeks

Abbreviations: BMI = body mass index; CDC = Centers for Disease Control and Prevention; CFB = change from baseline; NCHS = National Center for Health Statistics; MASH = metabolic dysfunction-associated steatohepatitis; MASLD = metabolic dysfunction-associated steatotic liver disease; PBO = placebo; PO = orally; T2D = type 2 diabetes.

a Must have undergone diet and exercise counseling for at least 3 months prior to screening.

bBased on age- and gender-specific growth chart determined by CDC-NCHS (2022).

cComorbidities include hypertension, T2D, prediabetes, dyslipidemia, obstructive sleep apnea, MASH, or MASLD.

Clinical Trials Comparing Orforglipron and Injectable GLP-1 RAs

Eli Lilly and Company does not have any ongoing clinical trials comparing the efficacy and safety of orforglipron with injectable GLP-1 receptor agonists or tirzepatide.

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).

1Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.

2Wharton 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

3Horn 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

4A study of once-daily oral orforglipron (LY3502970) in Japanese adult participants with obesity disease (ATTAIN-J). ClinicalTrials.gov identifier: NCT05931380. Updated August 27, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT05931380

5A master protocol for orforglipron in participants with obstructive sleep apnea and obesity or overweight (ATTAIN-OSA). ClinicalTrials.gov identifier: NCT06649045. Updated November 22, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT06649045

6A master protocol for orforglipron (LY3502970) in participants with hypertension and obesity or overweight: (ATTAIN-Hypertension screening). ClinicalTrials.gov identified NCT: NCT06948422. Updated April 29, 2025. Accessed May 2, 2025. https://clinicaltrials.gov/study/NCT06948422

7A study of orforglipron (LY3502970) in participants with obesity or overweight and osteoarthritis (OA) of the knee (ATTAIN-OA PAIN). ClinicalTrials.gov identifier: NCT07153471. Updated October 16, 2025. Accessed October 23, 2025. https://clinicaltrials.gov/study/NCT07153471

8Efficacy and safety of orforglipron in participants with peripheral artery disease (ATTAIN-PAD). ClinicalTrials.gov identifier: NCT07223593. Updated November 4, 2025. Accessed November 17, 2025. https://clinicaltrials.gov/study/NCT07223593

9A study of orforglipron in female participants with stress urinary incontinence who have obesity or overweight (RESTRAIN-SUI). ClinicalTrials.gov identifier NCT07202884. Updated October 16, 2025. Accessed October 24, 2025. https://clinicaltrials.gov/study/NCT07202884

10A study of orforglipron (LY3502970) on cardiovascular outcomes in adults with atherosclerotic cardiovascular disease and/or chronic kidney disease (ATTAIN-Outcomes). ClinicalTrials.gov identifier: NCT07241390. Updated November 21, 2025. Accessed November 21, 2025. https://clinicaltrials.gov/study/NCT07241390

11Lilly's orforglipron helped people maintain weight loss after switching from injectable incretins to oral GLP-1 therapy in first-of-its-kind Phase 3 trial. Press release. Eli Lilly and Company; December 18, 2025. Accessed December 18, 2025. https://investor.lilly.com/news-releases/news-release-details/lillys-orforglipron-helped-people-maintain-weight-loss-after

12A study of tirzepatide (LY3298176) in participants with obesity or overweight with weight related comorbidities (SURMOUNT-5). ClinicalTrials.gov identifier: NCT05822830. Updated August 27, 2024. Accessed December 6, 2024. https://clinicaltrials.gov/study/NCT05822830

13A master protocol study of orforglipron (LY3502970) in participants with hypertension and obesity or overweight (ATTAIN-Hypertension) GZL1. ClinicalTrials.gov identifier: NCT06952530. Updated April 29, 2025. Accessed May 12, 2025. https://clinicaltrials.gov/study/NCT06948435?term=GZL1&rank=1

14A master protocol study of orforglipron (LY3502970) in participants with hypertension and obesity or overweight (ATTAIN-Hypertension) GZL2. ClinicalTrials.gov identifier: NCT06952530. Updated May 1, 2025. Accessed May 12, 2025. https://clinicaltrials.gov/study/NCT06952530?term=GZL2&rank=1

15A platform trial for pediatric participants with obesity or overweight (LY900040) (ADVANCE). ClinicalTrials.gov identifier: NCT06672549. Updated April 18, 2025. Accessed April 18, 2025. https://clinicaltrials.gov/study/NCT06672549

16A study of orforglipron (LY3502970) in adolescent participants with obesity, or overweight with related comorbidities. ClinicalTrials.gov identifier: NCT06672939. Updated April 18, 2025. Accessed April 18, 2025. https://clinicaltrials.gov/study/NCT06672939

Date of Last Review: April 01, 2026

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Foundayo ™ (orforglipron) tablet