GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT04876027

CompletedPhase 4

GLP-1 RAs in Patients With Polycystic Ovary Syndrome (PCOS)

Dulaglutide and Calorie Restrict Diet (CRD) in Overweight/Obese Patients With Polycystic Ovary Syndrome

Lead sponsor

Shanghai 10th People's Hospital

Assets

Dulaglutide / GLP-1 / incretin class catch-all

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Obesity / overweight, PCOS

Key I/E criteria

•BMI ≥24•Female

Primary endpoint

•Visceral fat, 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 IDNCT04876027

Org study IDGLP-1RAs PCOS

Timeline

Milestones

Study first posted2021-05-06actual

Study start2021-05-15actual

Primary completion2022-04-30actual

Study completion2022-05-10actual

Last update posted2022-08-04actual

Assets

Investigational agents

Dulaglutide GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexFemale

Healthy volunteersNot accepted

Inclusion criteria

•Female aged 18- 45;

•Meet 2003 Rotterdam criteria;

•overweight/obesity,BMI≥24kg/m2.

Exclusion criteria

•any contraindication to dulaglutide (known or suspected hypersensitivity to dulaglutide or related products, previous acute pancreatitis or chronic pancreatitis, inflammatory bowel disease; personal history or family history of medullary thyroid carcinoma, or personal history of multiple endocrine neoplasia type 2)；

•treatment with any other drugs that may interfere with the trial, including traditional Chinese medicine, contraceptives, metformin, GLP-1RA or pioglitazone within the last 3 months；

•chronic kidney disease or severe liver dysfunction；

•malignant tumors；

•mental illness;

•pregnancy or lactation；

•inflammatory bowel disease;

•recent participation in other weight-loss research projects within the last 3 months.

Endpoints (33)

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

Other clinical outcomes

Weight & body composition

Glycemic / diabetes

MASH / liver

Renal / kidney

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

6 endpoints

Primary/protocol endpoint

the change in visceral adipose tissue

Time frame:until achievement of the weight loss target,an average of 12 weeks

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

total body fat

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

total body lean

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Lean mass

descriptive, improvement

Secondary/protocol endpoint

total fat mass

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

total lean mass

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

the change in subcutaneous adipose tissue

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Subcutaneous fat, change

change from baseline, improvement

Glycemic / diabetes

6 endpoints

Secondary/protocol endpoint

fasting plasma glucose

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

postprandial plasma glucose

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

fasting insulin

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

change from baseline, improvement

Secondary/protocol endpoint/low confidence

postprandial insulin

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

glycosylated hemoglobin A1c

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

descriptive, improvement

LOINC 4548-4

Secondary/protocol endpoint

homeostasis model assessment of insulin resistance

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

MASH / liver

4 endpoints

Secondary/protocol endpoint

alanine aminotransferase

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

aspartate aminotransferase

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

AST, change

change from baseline, improvement

LOINC 1920-8

Secondary/protocol endpoint

controlled attenuation parameter

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

liver stiffness measurement

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Liver stiffness (VCTE), change

change from baseline, improvement

Renal / kidney

1 endpoint

Secondary/protocol endpoint

Creatinine

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

descriptive

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

systolic blood pressure

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

diastolic blood pressure

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Total cholesterol

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Total cholesterol, change

change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Triglycerides

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

high-density lipoprotein cholesterol

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

low-density lipoprotein cholesterol

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

LDL-C, change

change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

serum uric acid

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint/low confidence

pituitary prolactin

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

change from baseline, descriptive

Other clinical outcomes

7 endpoints

Secondary/protocol endpoint

menstrual frequency

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Menstrual cyclicity

event count, improvement

Secondary/protocol endpoint/low confidence

luteinizing hormone

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

follicle-stimulating hormone

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

total testosterone

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

free testosterone

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Androstenedione

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

dehydroepiandrosterone sulfate

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

Androgen, change

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Sex hormone binding globulin

Time frame:from randomization to the time of achievement of the weight loss target, an average of 12 weeks

change from baseline, improvement

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.