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New Dual-Action shot could tame PCOS symptoms

NCT ID NCT07616037

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new weekly injection called HEC88473 in 30 women with polycystic ovary syndrome (PCOS). The drug targets two pathways to improve hormone levels and menstrual cycles. Researchers will track changes in free androgen index and menstrual regularity over 24 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HEC88473 (a GLP-1/FGF21 dual agonist)
What this could lead to
If successful, this could offer a new treatment option for PCOS that improves hormone balance and menstrual regularity.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply broadly. The drug may cause side effects or fail to show clear benefits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Zhongshan Hospital, Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 201508, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.