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Trial · Interventional

CompletedPhase 1/2Registry data

Efficacy of Mazdutide for Treating PCOS

NCTNCT06519656 (opens ClinicalTrials.gov in a new tab)Other idB2024-190R2
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Overview

Status
Completed
Phase
Phase 1/2
Enrollment
43 participants (actual)
Sponsor
Shanghai Zhongshan Hospital · Other
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

China

Start
21 Oct 2024
Primary completion
1 Sept 2026
Completion
18 Sept 2026
First posted
25 Jul 2024
Last update posted
21 Sept 2026
Conditions
Polycystic Ovary Syndrome

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2024202520262027
  1. Ph 1/2

    Efficacy of Mazdutide for Treating PCOS

    NCT06519656

    21 Oct 2024 to 18 Sept 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • MazdutideDrug

Arms1

  • Experimental

    Mazdutide Treatment Arm

    Subcutaneous injection of Mazdutide once weekly for 24 weeks.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Free Androgen Index (FAI)

    Time frame · 24 weeks

    Registry description

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

Secondary outcomes(7)

  1. Times of regular menses

    Time frame · 24 weeks

    Registry description

    Record of vaginal bleeding within 24 weeks after using Mazdutide

  2. Number of immature follicles

    Time frame · 24 weeks

    Registry description

    Total number of follicles measuring 2-9 mm in diameter on ultrasound

  3. Bilateral ovary volume

    Time frame · 24 weeks

    Registry description

    Total ovary volume is calculated based on length, width and height of bilateral ovaries measured by ultrasound

  4. Serum anti-Mullerian hormone (AMH)

    Time frame · 24 weeks

    Registry description

    Measurement of serum AMH

  5. HOMA insulin resistance index (HOMA-IR)

    Time frame · 24 weeks

    Registry description

    HOMA-IR=fasting plasma glucose (mmol/L)×fasting insulin (μU/mlINS)/22.5

  6. HbA1c

    Time frame · 24 weeks

    Registry description

    Measurement of HbA1c

  7. body mass index (BMI)

    Time frame · 24 weeks

    Registry description

    BMI = weight / height² (weight in kilograms and height in meters)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 40 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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