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Orforglipron-Obesity

This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling.

What orforglipron clinical trials are being conducted in people with obesity or overweight?

The ATTAIN and ADVANCE-ATTAIN clinical trial programs evaluate investigational doses of orforglipron for the treatment of obesity or overweight in adult and pediatric participants with or without comorbidities, respectively.

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Orforglipron Clinical Trial Program for the Treatment of Obesity or Overweight

Orforglipron is a novel, once-daily, oral, nonpeptide glucagon-like peptide-1 receptor agonist (GLP-1 RA) being developed for the treatment of obesity or overweight and the treatment of type 2 diabetes (T2D).1

ATTAIN Clinical Trials in Adult Participants

The ATTAIN clinical trial program assesses the efficacy and safety of investigational doses of orforglipron as a treatment for obesity or overweight in adult participants (Overview of the ATTAIN Phase 3 Clinical Trial Program of Orforglipron for the Treatment of Obesity or Overweight in Adult Participants).

Overview of the ATTAIN Phase 3 Clinical Trial Program of Orforglipron for the Treatment of Obesity or Overweight in Adult Participants
Trial and Target Population	Key Inclusion Criteria	Orforglipron Groups	Comparator	Primary Endpoint(s)	Primary Timepoint
Global Trials
ATTAIN-12 in People With Obesity or Overweight NCT05869903	BMI ≥30 kg/m², or BMI ≥27 kg/m² with ≥1 weight-related comorbidity without T2Da	Administered PO	PBO	Percent CFB in BW	72 weeks
ATTAIN-23 in People With Obesity or Overweight and T2D NCT05872620	BMI ≥27 kg/m² T2D	Administered PO	PBO	Percent CFB in BW	72 weeks
ATTAIN-OSA4 in People With OSA and Obesity or Overweight NCT06649045	BMI ≥27 kg/m² AHI ≥15 on PSG as part of the trial at screening (visit 1)b	Administered PO	PBO	CFB in AHI	52 weeks
ATTAIN-HYPERTENSTION5-7^,c in People With Hypertension and Obesity or Overweight NCT06948422	SBP ≥140 mm Hg and/or DBP ≥90 mm Hg at screening or week 0 (visit 1 or visit 3)d 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
Regional Trials
ATTAIN-J8 in Japanese People With Obesity NCT05931380	BMI ≥27 kg/m²and <35 kg/m² and at least 2 obesity-related health problemse BMI ≥35 kg/m² and at least 1 obesity-related health probleme	Administered PO	PBO	Percent CFB in BW	72 weeks
ATTAIN-MAINTAIN9 in People With Obesity or Overweight NCT06584916	Have completed the SURMOUNT-5 study on study treatment10 f	Administered PO	PBO	Percent maintenance of BW reduction achieved in SURMOUNT-5	52 weeks

Abbreviations: AHI = apnea-hypopnea index; BMI = body mass index; BW = body weight; CFB = change from baseline; DBP = diastolic blood pressure; HTN = hypertension; OSA = obstructive sleep apnea; PAP = positive airway pressure; PBO = placebo; PO = orally; PSG = polysomnography; SBP = systolic blood pressure; T2D = type 2 diabetes.

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

bATTAIN-OSA is a master protocol designed to support 2 independent studies, GZ01 and GZ02. The key inclusion criteria for GZ01 include 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 include 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.

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

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

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

fKey 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.

ADVANCE-ATTAIN Clinical Trials in Pediatric Patients

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.11

This PWMP establishes entry criteria for participants across the

master protocol, and
intervention-specific appendices.11

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
Global
ADVANCE-ATTAIN-ADOLESCENTS12 in Adolescent Participants With Obesity, or Overweight With Related Comorbidities NCT06672939	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 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 RAs or tirzepatide.

References

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

1Wharton S, Blevins T, Connery L, et al; GZGI Investigators. Daily oral GLP-1 receptor agonist orforglipron for adults with obesity. N Engl J Med. 2023;389(10):877-888. https://doi.org/10.1056/NEJMoa2302392

2A study of orforglipron (LY3502970) in adult participants with obesity or overweight with weight-related comorbidities (ATTAIN-1). ClinicalTrials.gov identifier: NCT05869903. Updated October 8, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT05869903

3A study of orforglipron in adult participants with obesity or overweight and type 2 diabetes (ATTAIN-2). ClinicalTrials.gov identifier: NCT05872620. Updated October 16, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT05872620

4A 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

5A 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

6A 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

7A 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

8A 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

9A study of orforglipron for the maintenance of body weight reduction in participants who have obesity or overweight with weight-related comorbidities (ATTAIN-MAINTAIN). ClinicalTrials.gov identifier: NCT06584916. Updated October 23, 2024. Accessed November 27, 2024. https://clinicaltrials.gov/study/NCT06584916

10A 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

11A 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

12A 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 18, 2025

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