A Phase 3 interventional study of Orforglipron and Placebo in Obesity and Overweight, sponsored by Eli Lilly and Company. Completed at 29 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-04.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction in participants who previously completed treatment with injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy) in the SURMOUNT-5 trial (NCT05822830).
All enrolled participants will have completed SURMOUNT-5 (I8F-MC-GPHJ; NCT05822830) on treatment and meet further eligibility and randomization criteria. SURMOUNT-5 randomized participants to either injectable tirzepatide (Zepbound) or injectable semaglutide (Wegovy); therefore, all ATTAIN-MAINTAIN participants had prior exposure to one of these injectable incretin-based therapies before transitioning directly to orforglipron 12 mg capsule or placebo. All endpoints for this study will be evaluated separately per each intervention arm of SURMOUNT-5.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's enrollment of 376 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →Eli Lilly and Company is the lead sponsor of 2,106 studies on the registry; 152 are open to participants now.
Of its 536 completed or terminated interventional studies of FDA-regulated products, 357 (67%) have results posted.
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Exclusion Criteria:
Participants will receive orforglipron orally
Drug: Orforglipron
Participants will receive placebo orally
Drug: Placebo
Administered orally
Administered orally
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
Time frame: Week 52
Percent Change from SURMOUNT-5 Baseline in Body Weight Prior to Start of Treatment
Time frame: Week 52
Number of Participants Maintaining ≥80% of the Body Weight Reduction Achieved in SURMOUNT-5
Time frame: Week 52
Change from Baseline in Body Weight
Time frame: Baseline, Week 52
Change from Baseline in Waist Circumference
Time frame: Baseline, Week 52
Percent Maintenance of Body Weight Reduction Achieved in SURMOUNT-5
Time frame: Week 24
Plan to share: Yes — Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data are available 6 months after the primary publication or approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Data sharing details ↗ · vivli.org
This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Orforglipron