AMPLIFY-1

Not yet recruitingPhase 3

A Study of EloraTZP in Adult Participants With Obesity Without Type 2 Diabetes

A Phase 3 Study to Investigate the Efficacy and Safety of LY900043 in Adult Participants With Obesity Without Type 2 Diabetes

Lead sponsor

Eli Lilly and Company

Assets

Eloralintide / Tirzepatide

Listed sites

155

Recruiting sites

Estimated enrollment

2,115

Study population

Obesity / overweight

Eligibility highlights

•BMI ≥35

Primary endpoint

•Body Weight

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 IDNCT07881432

Org study ID27836

Secondary ID2026-526047-34-00

Secondary IDJ7C-MC-YQAAEli Lilly and Company

Timeline

Milestones

Study first posted2026-10-19actual

Last update posted2026-11-03actual

Study start2026-12estimated (month precision)

Primary completion2029-10estimated (month precision)

Study completion2029-11estimated (month precision)

Assets

Investigational agents

Eloralintide Tirzepatide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have a stable self-reported body weight (<5% body weight change) for 90 days prior to screening

•Have a BMI of ≥35 kg/m2 at screening

•Have a history of at least 1 self-reported unsuccessful dietary effort to reduce body weight

Exclusion criteria

•Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)

•Have a prior or planned endoscopic procedure and/or device-based therapy for obesity and/or type 2 diabetes (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)

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

•Have had within 90 days prior to screening:

-heart attack

-stroke

-coronary artery revascularization

-unstable angina, or

-hospitalization due to congestive heart failure

•Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure

•Have taken any glucose-lowering medication within 90 days of screening

•Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Endpoints (21)

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

Safety / tolerability / PK

Glycemic / diabetes

Cardiometabolic biomarkers

Patient-reported / QoL

Other (unclassified)

Renal / kidney

Weight & body composition

6 endpoints

Primary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 100

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference

Time frame:Baseline, Week 100

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Total Body Fat Mass

Time frame:Baseline, Week 100

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Mass Index (BMI)

Time frame:Baseline, Week 100

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 100

change from baseline, improvement

Secondary/protocol endpoint

Achievement of Improved Categorical Shift in Patient Global Impression of Severity (PGIS) Physical Function Weight

Time frame:Baseline, Week 100

threshold achievement, improvement

Glycemic / diabetes

3 endpoints

Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 100

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Fasting Insulin

Time frame:Baseline, Week 100

percent change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants who Develop Type 2 Diabetes

Time frame:Baseline through Week 100

threshold achievement, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Change from Baseline in Estimated Glomerular Filtration Rate (eGFR)

Time frame:Baseline, Week 100

change from baseline, improvement

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 100

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure

Time frame:Baseline, Week 100

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)

Time frame:Baseline, Week 100

percent change from baseline, improvement

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

Change from Baseline in EQ-5D-5L Score

Time frame:Baseline, Week 100

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Eating Behaviors and Attitudes Questionnaire (EBAQ) Score

Time frame:Baseline, Week 100

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Concentration of Eloralintide at Steady State (Cmax,ss)

Time frame:Baseline through Week 100

concentration, descriptive

Secondary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve of Eloralintide for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)

Time frame:Baseline through Week 100

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Concentration of Tirzepatide at Steady State (Cmax,ss)

Time frame:Baseline through Week 100

concentration, descriptive

Secondary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve of Tirzepatide for One Dosing Interval at Steady State (AUC(0-ᴛ)ss)

Time frame:Baseline through Week 100

concentration, descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Percentage of Participants with a Change in Medication Use

Time frame:Baseline through Week 100

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Overall Functional Assessment of Chronic Illness Therapy, Item GP5 (FACT-GP5) Score

Time frame:Week 100

descriptive

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.