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ATTAIN-1

Active not recruitingPhase 3

A 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)

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

NCT IDNCT05869903
Org study ID18559
Secondary ID2022-502839-19-00Eli Lilly and Company
Secondary IDJ2A-MC-GZGPEli Lilly and Company
Secondary IDU1111-1289-8877UTN Number

Timeline

Milestones

Study first posted2023-05-22actual
Study start2023-06-05actual
Primary completion2025-07-25actual
Last update posted2025-11-05actual
Study completion2027-10estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

Have a BMI
≥30.0 kilogram/square meter (kg/m²),
≥27.0 kg/m² and presence of at least 1 of the following weight-related comorbidities (treated or untreated) at screening:
Hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure).
Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight.

Exclusion criteria

Have Type 1 diabetes, Type 2 diabetes, or any other types of diabetes, history of ketoacidosis, or hyperosmolar state/coma
Have a self-reported change in body weight >5 kg (11 pounds) within 90 days prior to screening.
Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia (MEN)2 syndrome.
Have had a history of chronic or acute pancreatitis.

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

Glycemic / diabetes
4
Cardiometabolic biomarkers
4
Weight & body composition
3
Patient-reported / QoL
1

Weight & body composition

3 endpoints
Primary/protocol endpoint

Mean Percent Change from Baseline in Body Weight

Time frame:Baseline to Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Mean Change from Baseline in Waist Circumference

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Mean Change from Baseline in Hemoglobin A1c (HbA1c) %

Time frame:Baseline, Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Mean Change from Baseline in Fasting Glucose

Time frame:Baseline, Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Mean Percent Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 72

percent change from baseline, improvement

Secondary/protocol endpoint

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 endpoints
Secondary/protocol endpoint

Mean Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Mean Percent Change from Baseline in Fasting non-HDL Cholesterol

Time frame:Baseline, Week 72

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Mean Percent Change from Baseline in Fasting Triglycerides

Time frame:Baseline, Week 72

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint

Mean 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

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.