DelfaGLP-1 Atlas

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RecruitingPhase 1, PHASE2

Efficacy of Mazdutide for Treating PCOS

A Clinical Efficacy Study of Mazdutide in the Treatment of Polycystic Ovary Syndrome

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

1

Enrollment

50

estimated

Study population

Obesity / overweight, PCOS

Key I/E criteria

•BMI ≥28•Female

Primary endpoint

•Androgen, 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 IDNCT06519656
Org study IDB2024-190R2

Timeline

Milestones

Study first posted2024-07-25actual
Study start2024-10-21actual
Last update posted2024-10-24actual
Primary completion2025-12-31estimated
Study completion2026-06-30estimated

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Obesity / overweightPCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•BMI≥28kg/M2
•No plan for pregnancy in the coming 8 months after enrollment
•Patients should meet at least two of the three criteria according to the 2023 international evidence-based guideline for PCOS :

1. Irregular cycles and ovulatory dysfunction: < 21 or > 35 days or < 8 cycles per year; > 90 days for any one cycle

2. Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter<10mm), confirmed by ultrasound

3. Biochemical hyperandrogenism: total testosterone>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)>4

Exclusion criteria

•Previous history of acute or chronic pancreatitis or pancreatic injury
•Previous history or family history of medullary thyroid cancer, multiple endocrine neoplasia type 2a or 2b
•Severe hypertriglyceridemia (TG>5mmol/L)
•Type 1 or type 2 diabetes mellitus
•Other endocrine diseases that can cause secondary PCOS, including but not limited to: 21 hydroxylase deficiency, prolactinoma, hypothyroidism, Cushing's syndrome, etc
•Pregnancy or breast-feeding
•Patients with other serious diseases affecting heart, liver, kidney, or other major organs
•Patients with any type of cancer

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

Other clinical outcomes
5
Glycemic / diabetes
2
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

body mass index (BMI)

Time frame:24 weeks

BMI, change

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

HOMA insulin resistance index (HOMA-IR)

Time frame:24 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

HbA1c

Time frame:24 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Other clinical outcomes

5 endpoints
Primary/protocol endpoint

Free Androgen Index (FAI)

Time frame:24 weeks

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Times of regular menses

Time frame:24 weeks

Menstrual cyclicity

event count, improvement

Secondary/protocol endpoint

Number of immature follicles

Time frame:24 weeks

descriptive

Secondary/protocol endpoint

Bilateral ovary volume

Time frame:24 weeks

change from baseline, descriptive

Secondary/protocol endpoint

Serum anti-Mullerian hormone (AMH)

Time frame:24 weeks

change from baseline, descriptive

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.