DelfaGLP-1 Atlas

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RecruitingPhase 2

Efficacy of a GLP-1/FGF21 Dual Agonist for Treating PCOS

A Preliminary Study to Explore the Efficacy of a GLP-1/FGF21 Dual Agonist (HEC88473) in Patients With Polycystic Ovary Syndrome (PCOS)

Asset

HEC88473

Subcutaneous · GLP-1 / FGF21 dual

Listed sites

1

Recruiting sites

1

Enrollment

30

estimated

Study population

PCOS

Key I/E criterion

•Female

Primary endpoint

•Free Androgen Index

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 IDNCT07616037
Org study IDB2025-709R

Timeline

Milestones

Study first posted2026-05-29actual
Last update posted2026-05-29actual
Study start2026-06estimated (month precision)
Primary completion2027-06estimated (month precision)
Study completion2027-12estimated (month precision)

Assets

Investigational agents

HEC88473

Study populations

Who this study enrolls

PCOS

Eligibility

Who can enroll

Minimum age18 Years
Maximum age40 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•Age between 18 and 40 years.
•Female.
•No plan for pregnancy from the time of signing the informed consent until 2 months after the last dose of study drug, and willingness to use study-approved contraceptive methods during this period.
•Fulfillment of at least two of the diagnostic criteria for PCOS according to the 2023 International Guideline, including:

1. Irregular menstrual cycles:

1-3 years after menarche: cycle length <21 days or >45 days; ≥3 years after menarche to perimenopause: cycle length <21 days or >35 days, or fewer than 8 menstrual cycles per year; ≥1 year after menarche: any cycle >90 days;

2. Polycystic ovarian morphology: at least one ovary with ≥20 antral follicles (diameter <10 mm), confirmed by transvaginal or transrectal pelvic ultrasonography;

3. Hyperandrogenism: biochemical hyperandrogenism (total testosterone >1.67 nmol/L) or clinical hyperandrogenism (modified Ferriman-Gallwey [mFG] score >4).

Exclusion criteria

•Use of hormonal contraceptives within 2 months prior to screening.
•History of acute or chronic pancreatitis or pancreatic injury.
•Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2A or 2B.
•History of type 1 or type 2 diabetes mellitus.
•Presence of other endocrine disorders that may cause polycystic ovarian morphology, such as 21-hydroxylase deficiency, pituitary prolactinoma, hypothyroidism, or Cushing's syndrome.
•Current use of other medications known to affect reproductive function, with discontinuation less than 2 months prior to screening, including GnRH agonists or antagonists, anti-androgens, and gonadotropins.
•Current use of other medications that may affect metabolism, with discontinuation less than 1 month prior to screening, including metformin, thiazolidinediones, and SGLT2 inhibitors.
•History of bariatric surgery within the past 12 months.
•Treatment with GLP-1 receptor agonists within the past 12 months.
•Pregnancy or lactation.
•Presence of other serious diseases of major organs such as the heart, liver, or kidney, or any malignancy.
•Any other condition that, in the investigator's opinion, may interfere with the evaluation of efficacy or safety or render the participant unsuitable for this study.

Endpoints (15)

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 (unclassified)
8
Weight & body composition
2
Patient-reported / QoL
2
Glycemic / diabetes
1
Cardiometabolic biomarkers
1
Safety / tolerability / PK
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint

Change From Baseline in HOMA IR Index at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change From Baseline in Lipid Profile at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Change From Baseline in Quality of Life Assessed by SF-36 at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Quality of Life Assessed by PCOSQ at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Incidence and Severity of Adverse Events During the 24-Week Treatment Period

Time frame:Baseline to Week 24.

descriptive

Other (unclassified)

8 endpoints
Primary/protocol endpoint/low confidence

Change From Baseline in Free Androgen Index Over 24 Weeks of Treatment

Time frame:Baseline to Week 24 (assessed at scheduled follow-up visits).

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in the Number of Spontaneous Menstrual Cycles During the 24-Week Treatment Period Compared With the 24-Week Pre-treatment Period

Time frame:24 weeks before treatment initiation to 24 weeks after treatment initiation.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Bilateral Antral Follicle Count (Diameter <10 mm) at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Bilateral Ovarian Volume at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Serum AMH at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Serum Total Testosterone at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Serum DHEA-S at Week 24

Time frame:Baseline to Week 24.

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Serum SHBG at Week 24

Time frame:Baseline to Week 24.

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.