ATTAIN-NOW

RecruitingPhase 3

A Study of Orforglipron in Participants With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of Once-Daily Oral Orforglipron Compared With Placebo in Individuals With Overweight at Risk of Development of Obesity-Related Complications or Progression to Class 1 Obesity

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

180

Recruiting sites

Estimated enrollment

2,001

Study population

Hypertension, Obesity / overweight, Prediabetes / glucose intolerance

Eligibility highlights

•BMI ≥25

Primary endpoint

•Onset of Obesity Related Complications or Class 1 Obesity

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07794579

Org study ID27823

Secondary ID2026-526175-35-00

Secondary IDJ2A-MC-GZVAEli Lilly and Company

Timeline

Milestones

Study start2026-08-26actual

Study first posted2026-08-31actual

Last update posted2026-11-05actual

Primary completion2029-08estimated (month precision)

Study completion2030-09estimated (month precision)

Assets

Investigational agents

Orforglipron

Who this study enrolls

HypertensionObesity / overweightPrediabetes / glucose intolerance

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have an increased waist-to-height ratio of ≥0.5

•Have at least one pre-obesity-related complication (prediabetes, prehypertension, predyslipidemia)

•Have at least one unsuccessful attempt to reduce body weight based on diet and exercise

•Have a BMI greater than or equal to 25 to less than or equal to 29.9 kg/m2 or equivalent-/region-specific overweight thresholds

Exclusion criteria

•Have type 1 diabetes, type 2 diabetes, or any other type of diabetes

•Do not have a stable body weight within 90 days before screening

•Have a documented obesity diagnosis or self-reported history of BMI ≥30 kg/m² (or an equivalent region-specific threshold)

•Have taken medications for weight loss, including over-the counter medications or alternative therapies, within 180 days prior to screening

•Have a prior or planned surgical treatment or procedure for obesity

•Have hypertension or history of hypertension

•Have dyslipidemia or history of dyslipidemia

Endpoints (13)

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

Glycemic / diabetes

Cardiometabolic biomarkers

Other clinical outcomes

Safety / tolerability / PK

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 104

percent change from baseline, improvement

Secondary/protocol endpoint

Time to Onset of Waist-to-Height Ratio ≥0.6

Time frame:Baseline to Week 104

threshold achievement, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Total Fat Mass

Time frame:Baseline, Week 104

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Score

Time frame:Baseline, Week 104

change from baseline, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Time to First Occurrence of Composite Endpoint of Type 2 Diabetes, Hypertension, Dyslipidemia

Time frame:Baseline to Week 104

time to event, event

Secondary/protocol endpoint

Time to Onset of Type 2 Diabetes

Time frame:Baseline to Week 104

time to event, event

Secondary/protocol endpoint

Change from Baseline in Glycated Hemoglobin (HbA1c)

Time frame:Baseline, Week 104

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure

Time frame:Baseline, Week 104

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 104

percent change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Pharmacokinetics (PK): Steady-State Area Under the Curve (AUC) of Orforglipron

Time frame:Week 4, 12, 24, 52, and 76

concentration, descriptive

Other clinical outcomes

2 endpoints

Primary/protocol endpoint

Time to Onset of Obesity Related Complications or Class 1 Obesity

Time frame:Baseline to Week 104

time to event, event

Secondary/protocol endpoint

Time to Onset of Class 1 Obesity

Time frame:Baseline to Week 104

time to event, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 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 November 5, 2026 snapshot.