GLP-1 Peptide Atlas, by Delfa

CompletedPhase 3

Effect of Retatrutide Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

A Phase 3, Randomized, Multicenter, Double-Blind Study to Investigate the Efficacy and Safety of Retatrutide Once Weekly Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (TRANSCEND-T2D-1)

Lead sponsor

Eli Lilly and Company

Asset

Retatrutide

Subcutaneous · GLP-1 / GIP / glucagon triple

Listed sites

Recruiting sites

—

Enrollment

537

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥23•HbA1c 7-9.5%

Primary endpoint

•HbA1c, 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 IDNCT06354660

Org study ID18804

Secondary IDJ1I-MC-GZBYEli Lilly and Company

Timeline

Milestones

Study first posted2024-04-09actual

Study start2024-04-10actual

Primary completion2026-01-22actual

Study completion2026-02-20actual

Last update posted2026-03-05actual

Assets

Investigational agents

Retatrutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have Type 2 Diabetes (T2D)

•Have HbA1c ≥ 7.0% to ≤ 9.5%

•Are naïve to insulin therapy and have not used oral or injectable antihyperglycemic (diabetes) medication for at least 90 days prior to screening

•Are of stable weight for at least 90 days prior to screening

•Have a Body Mass Index (BMI) ≥ 23.0 kilograms per meter squared (kg/m^2)

Exclusion criteria

•Have Type 1 Diabetes (T1D)

•Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening

•Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening

•Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema

•Have an estimated glomerular filtration rate (eGFR) <15 milliliters/minute/1.73 meter squared (mL/min/1.73 m^2) as determined by the central laboratory

•Have a prior or planned surgical treatment for obesity

•Have New York Heart Association Functional Classification IV congestive heart failure

•Have had an acute myocardial infarction, stroke, or were hospitalized for congestive heart failure within 90 days prior to screening

•Have a known clinically significant gastric emptying abnormality

•Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years

•Have any lifetime history of a suicide attempt

•Had chronic or acute pancreatitis

•Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) syndrome Type 2

•Have taken prescribed or over-the-counter medication, or alternative remedies, intended to promote body weight reduction within 90 days prior to screening.

Endpoints (14)

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

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

5 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline, Week 40

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Reduction of ≥ 5%

Time frame:Week 40

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Reduction of ≥ 10%

Time frame:Week 40

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Who Achieve Weight Reduction of ≥ 15%

Time frame:Week 40

≥15% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

6 endpoints

Primary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c) (%)

Time frame:Baseline, Week 40

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c < 7.0%

Time frame:Week 40

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c ≤ 6.5%

Time frame:Week 40

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c < 5.7%

Time frame:Week 40

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Serum Glucose

Time frame:Baseline, Week 40

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction

Time frame:Week 40

threshold achievement, improvement

componentsHbA1c <6.5% achievement, ≥10% weight-loss responders

Cardiometabolic biomarkers

3 endpoints

Secondary/protocol endpoint

Percent Change from Baseline in Triglycerides

Time frame:Baseline, Week 40

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percent Change from Baseline in Non- High-Density Lipoprotein (HDL) Cholesterol

Time frame:Baseline, Week 40

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Systolic Blood Pressure (SBP)

Time frame:Baseline, Week 40

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

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

Bajaj HS, Welch M, Shah P, Luna E, Jaouimaa FZ, Liu B, Liu R, Chen Y, Patel H, Bartee A. Efficacy and safety of retatrutide, a GIP, GLP-1, and glucagon receptor agonist, in people with type 2 diabetes and inadequate glycaemic control with diet and exercise (TRANSCEND-T2D-1): a double-blind, randomised, phase 3 trial. Lancet. 2026 Jun 6:S0140-6736(26)00967-0. doi: 10.1016/S0140-6736(26)00967-0. Online ahead of print.
PMID42250575via clinicaltrials gov reference derived

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.