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ATTAIN-1
Active not recruitingPhase 3A Study of Orforglipron (LY3502970) in Adult Participants With Obesity or Overweight With Weight-Related Comorbidities
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)
Lead sponsor
Asset
Orforglipron
Oral · GLP-1 agonist
Listed sites
138
Recruiting sites
—
Enrollment
3,127
actual
Study population
Obesity / overweight, Prediabetes / glucose intolerance
Key I/E criterion
—
Primary endpoint
•Body weight, % change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (12)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
3 endpointsMean Percent Change from Baseline in Body Weight
Time frame:Baseline to Week 72
Body weight, % change
percent change from baseline, improvement
Mean Change from Baseline in Waist Circumference
Time frame:Baseline, Week 72
Waist circumference, change
change from baseline, improvement
Mean Percent Change from Baseline in Body Weight in Participants with Prediabetes at Randomization
Time frame:Baseline, Week 176
Body weight, % change
percent change from baseline, improvement
Glycemic / diabetes
4 endpointsMean Change from Baseline in Hemoglobin A1c (HbA1c) %
Time frame:Baseline, Week 72
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Mean Change from Baseline in Fasting Glucose
Time frame:Baseline, Week 72
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Mean Percent Change from Baseline in Fasting Insulin
Time frame:Baseline, Week 72
percent change from baseline, improvement
Time to Onset of Type 2 Diabetes
Time frame:Baseline through Week 176, Baseline through Week 190
Time to T2DM onset
time to event, event
Cardiometabolic biomarkers
4 endpointsMean Change from Baseline in Systolic Blood Pressure (SBP)
Time frame:Baseline, Week 72
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Mean Percent Change from Baseline in Fasting non-HDL Cholesterol
Time frame:Baseline, Week 72
Non-HDL cholesterol, change
percent change from baseline, improvement
Mean Percent Change from Baseline in Fasting Triglycerides
Time frame:Baseline, Week 72
Triglycerides, change
percent change from baseline, improvement
LOINC 2571-8
Mean Change from Baseline in Diastolic Blood Pressure (DBP)
Time frame:Baseline, Week 72
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Patient-reported / QoL
1 endpointMean Change from Baseline in Short Form Version 2 (SF-36v2) Acute Form Domain Scores
Time frame:Baseline, Week 72
SF-36 total
change from baseline, improvement
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- The New England journal of medicine2025 Nov 6PMID40960239doi:10.1056/NEJMoa2511774via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.