GLP-1 Peptide Atlas, by Delfa

TerminatedPhase 2Results posted

A Preliminary Study of the Efficacy and Safety of MK-8521 for Type 2 Diabetes (MK-8521-004)

A Phase IIa, Multicenter, Placebo- and Active-controlled, Randomized, Double-Blind, Clinical Trial to Evaluate the Safety and Efficacy of MK-8521 Compared to Placebo in Subjects With Type 2 Diabetes Mellitus

Lead sponsor

Merck Sharp & Dohme LLC

Asset

Liraglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

176

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI 23-40

Primary endpoints

•HbA1c, change•Treatment-emergent AEs (any)•Discontinuation due to AE

Identifiers

Registered as

NCT IDNCT02492763

Org study ID8521-004

Secondary IDMK-8521-004Merck protocol number

Timeline

Milestones

Study first posted2015-07-09estimated

Study start2015-07-27actual

Primary completion2017-04-18actual

Study completion2017-04-18actual

Results first posted2018-03-08actual

Last update posted2018-09-10actual

Assets

Investigational agents

Liraglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age21 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have T2DM in accordance with American Diabetes Association guidelines

•Be on metformin monotherapy (>-1000 mg/day: metformin IR or metformin XR) for at least 12 weeks prior to study start with a hemoglobin A1C (A1C) >-7.5 and <-10.5% OR Be on dual therapy with metformin (>-1000 mg/day: dose stable for at least 4 weeks prior to study start) with an A1C of >-7.0% and <-10.0% and a second AHA and be willing to washout the second AHA. Allowable AHAs are dipeptidyl peptidase 4 (DPP-4 inhibitors), alpha-glucosidase inhibitors, sulfonylureas, and glinides.

•Have a body mass index (BMI) ≥23 kg/m^2 and ≤40 kg/m^2

•Is a female who is not of reproductive potential, or is a female of reproductive potential who agrees to avoid becoming pregnant: while receiving study drug and for 14 days after the last dose of study drug

Exclusion criteria

•Have a history of type 1 diabetes or a history of diabetic ketoacidosis

•Has a history of other specific types of diabetes (e.g., genetic syndromes, secondary pancreatic diabetes, diabetes due to endocrinopathies, drug- or chemical-induced, and post-organ transplant)

•Has been treated with any gut-derived incretin hormone glucagon-like peptide 1 (GLP-1) receptor agonist (e.g. Byetta™, Victoza™ or investigational agents) within the last 6 months or has had GLP-1 receptor agonist discontinued due to gastrointestinal intolerance or lack of efficacy. Note: treatment with a GLP-1 receptor agonist that was discontinued >6 months prior to study start is not an exclusion if the GLP-1 receptor agonist was discontinued for reasons other than gastrointestinal intolerance or lack of efficacy.

•Has a history of clinically significant gastrointestinal disorder (including diabetic gastroparesis; irritable bowel disease; recurrent episodes of nausea, vomiting, diarrhea and abdominal pain)

•Has a history of clinically significant and active, immunological, respiratory, genitourinary or major neurological (including stroke, transient ischemic attack and chronic seizures) abnormalities or diseases

•Has a history of cardiovascular disease (including diabetic cardiomyopathy) or significant cardiac condition (including a history of myocardial infarction, stable or unstable angina, arterial revascularization, pathologic, symptomatic or sustained tachyarrhythmia [e.g. atrial fibrillation, sustained supraventricular tachycardia, symptomatic non-sustained supraventricular tachycardia, ventricular tachycardia, ventricular fibrillation, Wolf-Parkinson-White syndrome, congenital long QT syndrome, etc.]) or heart failure

•Has a family history of medullary carcinoma of the thyroid or multiple endocrine neoplasm type-2 syndrome

•Has active diabetic proliferative retinopathy or a history of maculopathy

•Has human immunodeficiency virus (HIV)

•Has a medical history of active liver disease (other than non-alcoholic hepatic steatosis), including chronic hepatitis B or C (assessed by medical history), primary biliary cirrhosis, or active symptomatic gallbladder disease

•Is on a weight loss medication or has undergone bariatric surgery

•Has a history of acute or chronic pancreatitis of any etiology

•Had an event of severe hypoglycemia with neuroglycopenia in the past 12 months

•Has a positive urine pregnancy test

•Is pregnant or breast-feeding, or is planning to conceive during the trial, including 14 days following the last dose of investigational product

•Routinely consumes >1 alcoholic drinks per day or >7 alcoholic drinks per week or engages in binge drinking

•Routinely consumes ≥480mg /day caffeine in caffeinated beverages (1 cup of coffee contains approximately 120 mg of caffeine

•Is taking a beta blocker or medications with sympathomimetic activity (e.g. pseudoephedrine, phenylpropanolamine, etc.)

•Is currently a user of nicotine or nicotine containing products or does not agree to refrain from using nicotine during the trial, including 14 days following the last dose of investigational product

•Is currently a user of any illicit drugs (including any marijuana use) or has a history of drug (including alcohol) abuse within approximately 5 years

•has other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or blinded investigational product administration

Endpoints (24)

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

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/registry result

Change From Baseline in Body Weight at Week 12

Time frame:Baseline and Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Kilograms	95% CI
MK-8521 180 μg	-2.0	-2.9 – -1.1
MK-8521 300 μg	-3.0	-4.0 – -2.1
Placebo	-1.3	-2.2 – -0.3
Liraglutide 1.8 mg	-2.9	-3.8 – -1.9

Difference in Least Squares Means-0.795% CI-2.0 – 0.6p0.285Longitudinal data analysis

Difference in Least Squares Means0.995% CI-0.4 – 2.2p0.183Longitudinal data analysis

Difference in Least Squares Means-1.895% CI-3.1 – -0.4p0.010Longitudinal data analysis

Difference in Least Squares Means-0.295% CI-1.5 – 1.2p0.811Longitudinal data analysis

Difference in the Least Squares Means-1.695% CI-2.9 – -0.3p0.018Longitudinal data analysis

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 12

Time frame:Baseline and Week 12

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/registry result

Change From Baseline in Hemoglobin A1C (A1C) at Week 12

Time frame:Baseline and Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (least_squares_mean), Percent	95% CI
MK-8521 180 μg	-0.82	-1.16 – -0.49
MK-8521 300 μg	-1.05	-1.41 – -0.69
Placebo	-0.44	-0.80 – -0.08
Liraglutide 1.8 mg	-1.42	-1.77 – -1.07

Difference in Least Squares Means-0.3995% CI-0.88 – 0.11p0.126Longitudinal data analysis

Difference in Least Squares Means0.6095% CI0.11 – 1.08p0.017Longitudinal data analysis

Difference in Least Squares Means-0.6195% CI-1.12 – -0.10p0.018Longitudinal data analysis

Difference in Least Squares Means0.3795% CI-0.13 – 0.87p0.146Longitudinal data analysis

Difference in the Least Squares Means-0.9895% CI-1.49 – -0.48p<0.001Longitudinal data analysis

Primary/protocol endpoint

Change From Baseline in Hemoglobin A1C (A1C) at Week 12

Time frame:Baseline and Week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

Time frame:Baseline and Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (least_squares_mean), mg/dL	95% CI
MK-8521 180 μg	-13.7	-27.7 – 0.3
MK-8521 300 μg	-34.6	-49.3 – -19.9
Placebo	-5.1	-19.4 – 9.2
Liraglutide 1.8 mg	-42.9	-57.0 – -28.7

Difference in Least Squares Means-8.695% CI-28.2 – 10.9p0.385Longitudinal data analysis

Difference in Least Squares Means29.195% CI9.7 – 48.6p0.004Longitudinal data analysis

Difference in Least Squares Means-29.595% CI-49.6 – -9.4p0.004Longitudinal data analysis

Difference in Least Squares Means8.395% CI-11.7 – 28.2p0.416Longitudinal data analysis

Difference in the Least Squares Means-37.895% CI-57.5 – -18.0p<0.001Longitudinal data analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 12

Time frame:Baseline and Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

12 endpoints

Primary/registry result

Change From Baseline in Heart Rate at Week 12

Time frame:Baseline and Week 12

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), Beats/minute	95% CI
MK-8521 180 μg	5.47	2.99 – 7.96
MK-8521 300 μg	6.28	3.72 – 8.84
Placebo	-1.42	-3.92 – 1.07
Liraglutide 1.8 mg	1.63	-0.88 – 4.14

Difference in the LS Means vs. Placebo6.9095% CI3.42 – 10.37

Difference in LS Means vs. Liraglutide3.8495% CI0.35 – 7.33

Difference in LS Means vs. Placebo7.7095% CI4.17 – 11.23

Difference in LS Means vs. Liraglutide4.6595% CI1.11 – 8.19

Primary/protocol endpoint

Change From Baseline in Heart Rate at Week 12

Time frame:Baseline and Week 12

Heart rate, change

change from baseline, improvement

Secondary/registry result

Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12

Time frame:Baseline and Week 12

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Posted result

Group	Value (mean), mg/dL	95% CI
MK-8521 180 μg	-9.3	—
MK-8521 300 μg	8.8	—
Placebo	4.5	—
Liraglutide 1.8 mg	0.3	—

Secondary/registry result

Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12

Time frame:Baseline and Week 12

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Posted result

Group	Value (mean), mg/dL	95% CI
MK-8521 180 μg	-0.4	—
MK-8521 300 μg	-0.5	—
Placebo	3.8	—
Liraglutide 1.8 mg	0.4	—

Secondary/registry result

Change From Baseline in Fasting Triglycerides at Week 12

Time frame:Baseline and Week 12

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Posted result

Group	Value (mean), mg/dL	95% CI
MK-8521 180 μg	-2.9	—
MK-8521 300 μg	-26.6	—
Placebo	-15.6	—
Liraglutide 1.8 mg	-20.5	—

Secondary/registry result

Change From Baseline in Systolic Blood Pressure (SBP) at Week 12

Time frame:Baseline and Week 12

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
MK-8521 180 μg	-2.7	-6.4 – 0.9
MK-8521 300 μg	-1.5	-5.2 – 2.3
Placebo	1.0	-2.6 – 4.6
Liraglutide 1.8 mg	-1.7	-5.3 – 2.0

Difference in Least Squares Means-3.795% CI-8.8 – 1.4p0.151Longitudinal data analysis

Difference in Least Squares Means-1.195% CI-6.2 – 4.1p0.682Longitudinal data analysis

Difference in Least Squares Means-2.595% CI-7.7 – 2.7p0.344Longitudinal data analysis

Difference in Least Squares Means0.295% CI-5.0 – 5.4p0.948Longitudinal data analysis

Difference in the Least Squares Means-2.795% CI-7.8 – 2.5p0.306Longitudinal data analysis

Secondary/registry result

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12

Time frame:Baseline and Week 12

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (least_squares_mean), mmHg	95% CI
MK-8521 180 μg	0.5	-1.7 – 2.8
MK-8521 300 μg	0.4	-1.9 – 2.8
Placebo	-1.0	-3.3 – 1.3
Liraglutide 1.8 mg	0.6	-1.7 – 2.9

Difference in Least Squares Means1.595% CI-1.7 – 4.8p0.347Longitudinal data analysis

Difference in Least Squares Means-0.195% CI-3.3 – 3.2p0.963Longitudinal data analysis

Difference in Least Squares Means1.495% CI-1.9 – 4.7p0.394Longitudinal data analysis

Difference in Least Squares Means-0.295% CI-3.5 – 3.1p0.905Longitudinal data analysis

Difference in the Least Squares Means1.695% CI-1.6 – 4.9p0.325Longitudinal data analysis

Secondary/protocol endpoint

Change From Baseline in Fasting Low Density Lipoprotein (LDL) Cholesterol at Week 12

Time frame:Baseline and Week 12

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline in Fasting High Density Lipoprotein (HDL) Cholesterol at Week 12

Time frame:Baseline and Week 12

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline in Fasting Triglycerides at Week 12

Time frame:Baseline and Week 12

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP) at Week 12

Time frame:Baseline and Week 12

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 12

Time frame:Baseline and Week 12

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Safety / tolerability / PK

6 endpoints

Primary/registry result

Number of Participants With an Adverse Event (AE)

Time frame:Up to Week 14

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
MK-8521 180 μg	24	—
MK-8521 300 μg	29	—
Placebo	25	—
Liraglutide 1.8 mg	22	—

Primary/registry result

Number of Participants Who Discontinued Study Treatment Due to an AE

Time frame:Up to Week 12

Discontinuation due to AE

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
MK-8521 180 μg	3	—
MK-8521 300 μg	1	—
Placebo	2	—
Liraglutide 1.8 mg	2	—

Primary/registry result

Number of Participants With an AE of Symptomatic Hypoglycemia

Time frame:Up to Week 14

Documented hypoglycemia

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
MK-8521 180 μg	0	—
MK-8521 300 μg	2	—
Placebo	1	—
Liraglutide 1.8 mg	1	—

Difference in % vs Placebo-2.395% CI-12.1 – 5.6p0.301Miettinen & Nurminen method

Difference in % vs Placebo2.295% CI-8.1 – 13.2p0.573Miettinen & Nurminen method

Difference in % vs Liraglutide-2.495% CI-12.4 – 5.5p0.295Miettinen & Nurminen method

Difference in % vs Liraglutide2.295% CI-8.4 – 13.2p0.587Miettinen & Nurminen method

Primary/protocol endpoint

Number of Participants With an Adverse Event (AE)

Time frame:Up to Week 14

Treatment-emergent AEs (any)

event count, event

Primary/protocol endpoint

Number of Participants Who Discontinued Study Treatment Due to an AE

Time frame:Up to Week 12

Discontinuation due to AE

event count, event

Primary/protocol endpoint

Number of Participants With an AE of Symptomatic Hypoglycemia

Time frame:Up to Week 14

Documented hypoglycemia

event count, event

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.