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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 clinical trial program evaluates investigational doses of orforglipron for the treatment of obesity or overweight in adults with or without comorbidities.
ATTAIN Clinical Trial Program: Orforglipron for the Treatment of Obesity or Overweight
Orforglipron is a novel, once-daily, oral, nonpeptide glucagon-like peptide-1 (GLP-1) receptor agonist being developed for the treatment of obesity or overweight and the treatment of type 2 diabetes (T2D).1
The ATTAIN clinical trial program assesses the efficacy and safety of investigational doses of orforglipron as a treatment for obesity or overweight (Overview of the ATTAIN Phase 3 Clinical Trial Program of Orforglipron for the Treatment of Obesity or Overweight).
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.
Trial and Target Population |
Key Inclusion Criteria |
Orforglipron Groups |
Comparator |
Primary Endpoint(s) |
Primary Timepoint |
Global Trials |
|||||
ATTAIN-12 |
|
Administered PO |
PBO |
Percent CFB in BW |
72 weeks |
ATTAIN-23 |
|
Administered PO |
PBO |
Percent CFB in BW |
72 weeks |
ATTAIN-OSA4 |
|
Administered PO |
PBO |
CFB in AHI |
52 weeks |
Regional Trials |
|||||
ATTAIN-J5 |
Administered PO |
PBO |
Percent CFB in BW |
72 weeks |
|
ATTAIN-MAINTAIN6 |
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; OSA = obstructive sleep apnea; PAP = positive airway pressure; PBO = placebo; PO = orally; PSG = polysomnography; 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.
cComorbidities can be treated or untreated and should include either hypertension, dyslipidemia, or T2D.
dKey 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.
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 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
6A 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
7A 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
Date of Last Review: March 24, 2025