DelfaGLP-1 Atlas

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CompletedPhase 1Results posted

A Study of LY3493269 in Participants With Type 2 Diabetes

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Subcutaneous Doses of LY3493269 in Patients With Type 2 Diabetes Mellitus

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

3

Recruiting sites

—

Enrollment

56

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI 23-50•HbA1c ≥7%

Primary endpoint

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), Serious AEs (any))

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 IDNCT04515576
Org study ID17530
Secondary IDJ1X-MC-GZHCEli Lilly and Company

Timeline

Milestones

Study first posted2020-08-17actual
Study start2020-08-25actual
Primary completion2021-03-09actual
Study completion2021-03-09actual
Last update posted2025-01-14actual
Results first posted2025-01-14actual

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Are male or female not of childbearing potential
•Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening
•Have had a stable body weight (<5% body weight change) for the 3 months prior to screening
•Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening
•Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. Patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for inclusion if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening
•Have an HbA1c of at least 7.0% and no more than 10.5% at screening
•Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator

Exclusion criteria

•Have type 1 diabetes mellitus or latent autoimmune diabetes in adults
•Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
•Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment
•Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
•Have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea
•Have a history of acute or chronic pancreatitis
•Have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma
•Have calcitonin levels of 20 picograms per millilitre (pg/mL) or more at screening

Endpoints (8)

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

Safety / tolerability / PK
6
Glycemic / diabetes
2

Glycemic / diabetes

2 endpoints
Secondary/registry result

Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose

Time frame:Baseline, Day 29

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

GroupValue (mean), millimoles per litre (mmol/L)95% CI
Placebo-1.07—
1.5 mg Dulaglutide-4.11—
0.3 mg LY3493269-2.20—
1 mg LY3493269-4.83—
0.75/1.5/3 mg LY3493269-3.61—
1.5/3/4/5 mg LY3493269-3.98—
Secondary/protocol endpoint

Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose

Time frame:Baseline, Day 29

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

6 endpoints
Primary/registry result

Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline through final follow-up at Day 57

Treatment-emergent AEs (any)

descriptive

componentsTreatment-emergent AEs (any), Serious AEs (any)

Posted result

GroupValue (count_of_participants), Participants95% CI
PlaceboSAEs Related to Study Drug Administration0—
TEAEs Related to Study Drug Administration2—
1.5 mg DulaglutideSAEs Related to Study Drug Administration0—
TEAEs Related to Study Drug Administration5—
0.3 mg LY3493269SAEs Related to Study Drug Administration0—
TEAEs Related to Study Drug Administration3—
1 mg LY3493269SAEs Related to Study Drug Administration0—
TEAEs Related to Study Drug Administration7—
0.75/1.5/3 mg LY3493269SAEs Related to Study Drug Administration0—
TEAEs Related to Study Drug Administration10—
1.5/3/4/5 mg LY3493269SAEs Related to Study Drug Administration0—
TEAEs Related to Study Drug Administration13—
Primary/protocol endpoint

Number of Participants With One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline through final follow-up at Day 57

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269

Time frame:Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

concentration, descriptive

Posted result

GroupValue (geometric_least_squares_mean), nanogram*hour per milliliter (ng*h/mL)95% CI
0.3 mg LY3493269 QWWeek 14220—
Week 410600—
1 mg LY3493269 QWWeek 118500—
Week 438500—
0.75/1.5/3 mg LY3493269 QWWeek 110200—
Week 4105000—
1.5/3/4/5 mg LY3493269 QWWeek 122800—
Week 4123000—
Secondary/registry result

PK: Maximum Observed Drug Concentration (Cmax) of LY3493269

Time frame:Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram per milliliter (ng/mL)95% CI
0.3 mg LY3493269 QWWeek 131.2—
Week 480.3—
1 mg LY3493269 QWWeek 1153—
Week 4287—
0.75/1.5/3 mg LY3493269 QWWeek 173.6—
Week 4818—
1.5/3/4/5 mg LY3493269 QWWeek 1165—
Week 4920—
Secondary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269

Time frame:Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Observed Drug Concentration (Cmax) of LY3493269

Time frame:Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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.