NCT06519656

Brief Summary

The goal of this clinical trial is to learn the efficacy of Mazdutide in treating obese female adults diagnosed with polycystic ovary syndrome (PCOS). The main question it aims to answer is: Does Mazdutide lower the free androgen index (FAI) in obese female adults with PCOS? Participants will take Mazdutide once every week for 24 weeks and visit the clinic once every 4 weeks for checkups and tests.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
2mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress91%
Oct 2024Jun 2026

First Submitted

Initial submission to the registry

July 14, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

October 24, 2024

Status Verified

October 1, 2024

Enrollment Period

1.2 years

First QC Date

July 14, 2024

Last Update Submit

October 22, 2024

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Free Androgen Index (FAI)

    FAI=total testosterone (nmol/L)/ sex hormone binding globulin (nmol/L) X 100

    24 weeks

Secondary Outcomes (7)

  • Times of regular menses

    24 weeks

  • Number of immature follicles

    24 weeks

  • Bilateral ovary volume

    24 weeks

  • Serum anti-Mullerian hormone (AMH)

    24 weeks

  • HOMA insulin resistance index (HOMA-IR)

    24 weeks

  • +2 more secondary outcomes

Study Arms (1)

Mazdutide Treatment Arm

EXPERIMENTAL

Subcutaneous injection of Mazdutide once weekly for 24 weeks.

Drug: Mazdutide

Interventions

MazdutideDRUG

In the initial 4 weeks, the subjects are given Mazdutide 2mg once weekly. If well tolerated, the dosage is increased to 4mg once weekly for another 4 weeks. If still well tolerated, the dosage is further increased to 6mg once weekly and maintained for the ensuing 16 weeks.

Also known as: GLP-1R and GCGR dual agonist
Mazdutide Treatment Arm

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 :
  • Irregular cycles and ovulatory dysfunction: \< 21 or \> 35 days or \< 8 cycles per year; \> 90 days for any one cycle
  • Polycystic ovaries: ≥20 follicles in at least one of two ovaries (diameter\<10mm), confirmed by ultrasound
  • Biochemical hyperandrogenism: total testosterone\>1.67 nmol/L or clinical hyperandrogenism: modified Ferriman Gallwey score (mFG)\>4

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital Fudan University

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

mazdutideGlucagon-Like Peptide-1 Receptor

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide ReceptorsReceptors, G-Protein-CoupledReceptors, Cell SurfaceMembrane ProteinsProteinsAmino Acids, Peptides, and ProteinsReceptors, Gastrointestinal HormoneReceptors, Peptide

Study Officials

  • XI DONG, MD

    Fudan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

LIANGSHAN MU, MD, PhD

CONTACT

02164041990mu.liangshan@zs-hospital.sh.cn

JINGJING JIANG, MD, PhD

CONTACT

02164041990jiang.jingjing@zs-hospital.sh.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2024

First Posted

July 25, 2024

Study Start

October 21, 2024

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

October 24, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)