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NCT06584916
A Study of Orforglipron for the Maintenance of Body Weight Reduction in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-MAINTAIN)
Phase 3 trial testing Orforglipron in Obesity in 376 participants. Completed in 21 November 2025.
21 November 2025
Quick facts
| Lead sponsor | Eli Lilly and Company |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 376 |
| Start date | 13 September 2024 |
| Primary completion | 21 November 2025 |
| Estimated completion | 21 November 2025 |
| Sites | 29 locations across Puerto Rico, United States |
Drugs / interventions tested
- Orforglipron — full drug profile →
- Placebo
Conditions studied
- Obesity — all drugs for Obesity →
- Overweight — all drugs for Overweight →
Sponsor
Eli Lilly and Company — full company profile →
Who can join
18 and older, any sex, with Obesity or Overweight. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The main purpose of this study is to evaluate the efficacy and safety of orforglipron on maintenance of body weight reduction.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
New pharmacological agents and novel cardiovascular pharmacotherapy strategies in 2024.
Tamargo J, Agewall S, Ambrosio G, Borghi C, et al · · 2025 · cited 6× · PMID 40058879 · DOI 10.1093/ehjcvp/pvaf012 -
An Overview of Existing and Emerging Weight-Loss Drugs to Target Obesity-Related Complications: Insights from Clinical Trials.
Kim MK, Kim HS. · · 2025 · cited 4× · PMID 39696983 · DOI 10.4062/biomolther.2024.228 -
Tirzepatide for the Maintenance of Body Weight Reduction: Rationale, Design, and Baseline Characteristics of SURMOUNT-MAINTAIN.
Horn DB, Aronne LJ, Wharton S, Bays HE, et al · · 2025 · cited 1× · PMID 40916045 · DOI 10.1002/oby.70014 -
Orforglipron for maintenance of body weight reduction: the double-blind, randomized phase 3b ATTAIN-MAINTAIN trial.
Aronne LJ, Horn DB, le Roux CW, Chao AM, et al · · 2026 · PMID 42120723 · DOI 10.1038/s41591-026-04386-7 -
Oral Treatment of Obesity by GLP-1 and Its Analogs.
Holler N, Ruseska I, Schachner-Nedherer AL, Zimmer A, et al · · 2025 · PMID 41471111 · DOI 10.3390/pharmaceutics17121596
Verify or expand the search:
- PubMed search for NCT06584916
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Orforglipron
Trials testing the same drug.
- NCT06824051 — A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight · Phase 1 · completed
- NCT06692348 — A Study of Orforglipron (LY3502970) to Compare a Single Capsule and Multiple Capsules in Healthy Participants · Phase 1 · completed
- NCT06704763 — A Drug-Drug Interaction Study of Orforglipron (LY3502970) With Quinidine in Healthy Participants · Phase 1 · completed
- NCT06440980 — A Study to Compare Tablets and Capsules of Orforglipron (LY3502970) in Healthy Participants Who Are Obese or Overweight · Phase 1 · completed
- NCT06370728 — A Drug-Drug Interaction (DDI) Study of Orforglipron With Carbamazepine in Healthy Participants · Phase 1 · completed
Other recruiting trials for Obesity
Currently open trials in the same condition.
- NCT07403604 — Effect of Insulin Lowering on Lipogenesis · Phase 1 · recruiting
- NCT07509307 — AMAZE 6: A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee · Phase 3 · recruiting
- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07481630 — A Research Study Investigating How Well the Medicine NNC0487-0111 Helps People With Excess Body Weight and Knee Osteoart · Phase 3 · recruiting
- NCT07527195 — Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscl · Phase 1 · recruiting
Other Eli Lilly and Company trials
Trials by the same sponsor.
- NCT07533006 — A Study of LY4005130 in Adult Participants With Severe Alopecia Areata (Hair Loss) · Phase 2 · not yet recruiting
- NCT07533019 — A Study of LY4005130 in Adult Participants With Non-Segmental Vitiligo · Phase 2 · not yet recruiting
- NCT07247357 — A Study of LY4064809 in Healthy Adult Chinese Participants · Phase 1 · completed
- NCT07124013 — A Study of Olomorasib (LY3537982) in Healthy Japanese Participants · Phase 1 · completed
- NCT07030127 — A Study of LY3985863 in Healthy Participants · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06584916 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Eli Lilly and Company
- Last refreshed: 22 December 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06584916.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing