Study S001722

A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities (ATTAIN-1)

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05869903
Acronym: ATTAIN-1
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE3
Masking: DOUBLE
Status: ACTIVE_NOT_RECRUITING
Enrollment: 3127
Start: 2023-06-05
Primary completion: 2025-07-25
Lead sponsor: Eli Lilly and Company
Conditions: Obesity; Overweight; Overweight or Obesity
Interventions: DRUG:Orforglipron; DRUG:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:J2A-MC-GZGP; OTHER:2022-502839-19-00; OTHER:U1111-1289-8877

Registered primary outcomes

Percent Change From Baseline in Body Weight (Primary Treatment Period) [Baseline, Week 72]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0001832	Orforglipron for obesity treatment in older patients ≥65 years with or without type 2 diabetes: A post hoc subgroup analysis of the ATTAIN-1 and ATTAIN-2 trials. Horn DB, Obesity pillars	2026	Randomized trial	PMID 42577069 DOI	cites ClinicalTrials.gov:NCT05869903; registry reference DERIVED:42577069
R0010658	Predicting the Long-Term Risk of Type 2 Diabetes and Cardiovascular Disease With Orforglipron in People With Overweight or Obesity: A Post Hoc Analysis of the ATTAIN-1 Trial. Shinde S, Diabetes, obesity & metabolism	2026	Other trial	PMID 42750540 DOI	cites ClinicalTrials.gov:NCT05869903; registry reference DERIVED:42750540
R0006537	Orforglipron, an Oral Small-Molecule GLP-1 Receptor Agonist for Obesity Treatment. Wharton S, The New England journal of medicine	2025	Randomized trial	PMID 40960239 DOI	cites ClinicalTrials.gov:NCT05869903; registry reference DERIVED:40960239