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Active not recruitingPhase 3

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

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

NCT IDNCT06972459
Org study ID27361

Timeline

Milestones

Study first posted2025-05-15actual
Study start2025-05-15actual
Last update posted2026-04-24actual
Primary completion2027-08estimated (month precision)
Study completion2027-08estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have body mass index (BMI) ≥30 kilograms per square meter (kg/m2) or BMI ≥25.0 kg/m2 and at least 1 of the following weight-related comorbidities at screening:
hypertension
dyslipidemia
obstructive sleep apnea, or
cardiovascular disease
Have a history of at least one unsuccessful dietary effort to lose body weight

Exclusion criteria

Have type 1 diabetes, type 2 diabetes, or any other types of diabetes
Have an unstable body weight within 90 days prior to screening
Have New York Heart Association functional classification IV congestive heart failure or an acute cardiovascular condition within 90 days prior to screening
Have acute or chronic hepatitis or pancreatitis
Are taking other medications or alternative remedies to manage weight loss

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
Glycemic / diabetes
2
Cardiometabolic biomarkers
2
Patient-reported / QoL
1
Safety / tolerability / PK
1

Weight & body composition

4 endpoints
Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving Weight Reduction of ≥5%

Time frame:Baseline up to 72 weeks

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline up to 72 weeks

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 72

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline up to 72 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline up to 72 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Change from Baseline in EQ-5D-5L

Time frame:Baseline, Week 72

EQ-5D index

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Pharmacokinetics (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 identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.