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A Study of Orforglipron (LY3502970) in Participants With Obesity or Overweight and at Least One Weight-Related Comorbidity
A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes
Lead sponsor
Asset
Orforglipron
Oral · GLP-1 agonist
Listed sites
80
Recruiting sites
—
Enrollment
600
estimated
Study population
Obesity / overweight
Key I/E criterion
•BMI ≥30
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 (10)
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
4 endpointsPercent Change from Baseline in Body Weight
Time frame:Baseline, Week 72
Body weight, % change
percent change from baseline, improvement
Percentage of Participants Achieving Weight Reduction of ≥5%
Time frame:Baseline up to 72 weeks
≥5% weight-loss responders
threshold achievement, improvement
Change from Baseline in Waist Circumference
Time frame:Baseline up to 72 weeks
Waist circumference, change
change from baseline, improvement
Change from Baseline in Body Mass Index (BMI)
Time frame:Baseline, Week 72
BMI, change
change from baseline, improvement
Glycemic / diabetes
2 endpointsChange from Baseline in Hemoglobin A1c (HbA1c)
Time frame:Baseline up to 72 weeks
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change from Baseline in Fasting Glucose
Time frame:Baseline up to 72 weeks
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Cardiometabolic biomarkers
2 endpointsChange from Baseline in Systolic Blood Pressure (SBP)
Time frame:Baseline up to 72 weeks
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Percent Change from Baseline in Triglycerides
Time frame:Baseline up to 72 weeks
Triglycerides, change
percent change from baseline, improvement
LOINC 2571-8
Patient-reported / QoL
1 endpointChange from Baseline in EQ-5D-5L
Time frame:Baseline, Week 72
EQ-5D index
change from baseline, improvement
Safety / tolerability / PK
1 endpointPharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Orforglipron
Time frame:Predose through Week 48
Plasma concentration (steady state)
concentration, descriptive
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.