GLP-1 Peptide Atlas, by Delfa

CompletedPhase 2Results posted

A Study of Investigational Dulaglutide Doses in Participants With Type 2 Diabetes on Metformin Monotherapy

A Phase 2, Double-Blind, Placebo-Controlled, 18-Week Trial of Investigational Dulaglutide Doses Versus Placebo in Patients With Type 2 Diabetes on Metformin Monotherapy

Lead sponsor

Eli Lilly and Company

Asset

Dulaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

318

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥25•HbA1c 7-10%

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 IDNCT02973100

Org study ID16568

Secondary ID2016-002494-34

Secondary IDH9X-MC-GBGJEli Lilly and Company

Timeline

Milestones

Study first posted2016-11-25estimated

Primary completion2017-07-15actual

Study completion2017-08-14actual

Results first posted2018-08-24actual

Last update posted2019-09-23actual

Study start2016-12 (month precision)

Assets

Investigational agents

Dulaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have had type 2 diabetes (T2D) for ≥6 months according to the World Health Organization (WHO) classification

•Have HbA1c of 7.0% to 10.0%, inclusive, as assessed by the central laboratory

•Have been treated with stable doses of metformin for at least 3 months

•Have a body mass index (BMI) ≥25 kilograms per square meter

Exclusion criteria

•Have type 1 diabetes (T1D)

•Have used any glucose-lowering medication other than metformin 3 months prior to study entry or during screening/lead-in period or have used any glucagon-like peptide-1 receptor agonists (GLP-1 RAs) at any time in the past

•Have had any of the following cardiovascular conditions: acute myocardial infarction (MI), New York Heart Association Class III or Class IV heart failure, or cerebrovascular accident (stroke)

•Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial

•Have had chronic or acute pancreatitis any time prior to study entry

•Have an estimated glomerular filtration rate (eGFR) <45 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation

•Have serum calcitonin ≥20 picograms per milliliter, as determined by the central laboratory at study entry

Endpoints (16)

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

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Body Weight

Time frame:Baseline, Week 18

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilograms (Kg)	95% CI
Placebo	-1.6	—
Dulaglutide 1.5mg	-2.8	—
Dulaglutide 3.0mg	-3.9	—
Dulaglutide 4.5mg	-4.1	—

Mean Difference (Final Values)-1.295% CI-2.3 – -0.2p0.025Mixed Models Analysis

Mean Difference (Final Values)-2.495% CI-3.4 – -1.3p<0.001Mixed Models Analysis

Mean Difference (Final Values)-2.695% CI-3.7 – -1.5p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight

Time frame:Baseline, Week 18

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 18

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percentage of glycosylated hemoglobin	95% CI
Placebo	-0.44	—
Dulaglutide 1.5mg	-1.23	—
Dulaglutide 3.0mg	-1.31	—
Dulaglutide 4.5mg	-1.40	—

Mean Difference (Final Values)-0.8095% CI-1.07 – -0.53p<.001Mixed Models Analysis

Mean Difference (Final Values)-0.8795% CI-1.14 – -0.60p<0.001Mixed Models Analysis

Mean Difference (Final Values)-0.9695% CI-1.24 – -0.69p<.001Mixed Models Analysis

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1c (HbA1c)

Time frame:Baseline, Week 18

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Percentage of Participants With HbA1c of <7.0%

Time frame:Week 18

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	20	—
Dulaglutide 1.5mg	71.2	—
Dulaglutide 3.0mg	71.2	—
Dulaglutide 4.5mg	68.2	—

Odds Ratio (OR)24.48995% CI8.368 – 71.667p<.001Regression, Logistic

Odds Ratio (OR)27.90695% CI9.238 – 84.300p<.001Regression, Logistic

Odds Ratio (OR)21.85295% CI7.672 – 62.242p<.001Regression, Logistic

Secondary/registry result

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 18

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), millimole/liter (mmol/L)	95% CI
Placebo	-0.69	—
Dulaglutide 1.5mg	-2.01	—
Dulaglutide 3.0mg	-1.92	—
Dulaglutide 4.5mg	-2.11	—

Mean Difference (Final Values)-1.3295% CI-2.02 – -0.62p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.2395% CI-1.91 – -0.54p<0.001Mixed Models Analysis

Mean Difference (Final Values)-1.4295% CI-2.12 – -0.72p<0.001Mixed Models Analysis

Secondary/protocol endpoint

Percentage of Participants With HbA1c of <7.0%

Time frame:Week 18

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Glucose (FSG)

Time frame:Baseline, Week 18

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Safety / tolerability / PK

8 endpoints

Secondary/registry result

Percentage of Participants Discontinuing Study Drug Due to Adverse Events

Time frame:Baseline through Week 18

Discontinuation due to AE

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	95% CI
Placebo	4.9	—
Dulaglutide 1.5mg	6.2	—
Dulaglutide 3.0mg	10.1	—
Dulaglutide 4.5mg	13.2	—

Secondary/registry result

Rate of Documented Symptomatic Hypoglycemia

Time frame:Week 18

Documented hypoglycemia

event count, event

Posted result

Group	Value (least_squares_mean), Episodes/participant/365.25 days	95% CI
Placebo	0.00	—
Dulaglutide 1.5mg	0.00	—
Dulaglutide 3.0mg	0.00	—
Dulaglutide 4.5mg	0.00	—

Secondary/registry result

Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide

Time frame:0, 2, 4, 6, 10, 18, 22 weeks and early termination

Cmax

concentration, descriptive

Posted result

Group	Value (mean), nanogram per milliliter (ng/mL)	95% CI
Dulaglutide 1.5mg	90.4	38.9 – 170
Dulaglutide 3.0mg	151	64.3 – 277
Dulaglutide 4.5mg	204	87.2 – 377

Secondary/registry result

Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide

Time frame:0, 2, 4, 6, 10, 18, 22 weeks and early termination

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (mean), nanogramhour per milliliter (ngh/mL)	95% CI
Dulaglutide 1.5mg	11800	5300 – 21300
Dulaglutide 3.0mg	26700	15300 – 41400
Dulaglutide 4.5mg	36600	21100 – 56500

Secondary/protocol endpoint

Percentage of Participants Discontinuing Study Drug Due to Adverse Events

Time frame:Baseline through Week 18

Discontinuation due to AE

threshold achievement, event

Secondary/protocol endpoint

Rate of Documented Symptomatic Hypoglycemia

Time frame:Week 18

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Pharmacokinetics (PK): The Maximum Drug Concentration at Steady State (Cmax,ss) of Dulaglutide

Time frame:0, 2, 4, 6, 10, 18, 22 weeks and early termination

Cmax

concentration, descriptive

Secondary/protocol endpoint

Pharmacokinetics: Area Under the Concentration-Time Curve at Steady State From Time Zero to 168 Hours (AUC[0-168], ss) of Dulaglutide

Time frame:0, 2, 4, 6, 10, 18, 22 weeks and early termination

AUC₀–∞

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.