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Could ozempic help men become fathers? new trial investigates

NCT ID NCT07179120

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This study tests whether two popular weight-loss drugs, semaglutide and tirzepatide, can improve sperm quality and help obese men have children naturally. About 180 men will receive either lifestyle advice, semaglutide, or tirzepatide for 32 weeks. Researchers will measure changes in sperm count, movement, and pregnancy rates in their partners.

What this could mean

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

Active substance
Semaglutide (Rybelsus) and Tirzepatide (Mounjaro) – weekly injections
What this could lead to
If successful, these drugs could offer a new way to improve sperm quality and natural pregnancy rates in obese men struggling with infertility.
What could go wrong
This is an early phase 2 trial with only 180 men, so results may not apply to everyone. Side effects like nausea and rare risks (pancreatitis) are possible.

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 180 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Jan 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

20 to 45 years

Sex

Male 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: * (1) Married men aged 20-45 (considering childbearing age and ensuring fertility requirements), with female spouses \<40 years old and no significant infertility factors. (2) Meeting China's adult obesity criteria: BMI ≥28 kg/m² or meeting central obesity criteria (waist circumference ≥90 cm). (3) Meeting WHO diagnostic criteria for male infertility: Failure to achieve pregnancy after ≥1 year of unprotected normal sexual activity, diagnosed as male-factor infertility after basic evaluation (e.g., oligospermia, asthenospermia, or high sperm deformity rate; excluding azoospermia), with essentially normal fertility function in the female spouse. (4) Abnormal semen analysis: Baseline semen testing shows low sperm concentration or motility (e.g., sperm concentration \<15×10⁶/mL or progressive motility \<32%). (5) Willing to undergo randomization and corresponding interventions, able to attend regular follow-ups, and provide semen and blood samples. (6) Informed consent to participate in the study and signing of the informed consent form. Exclusion Criteria: * (1) Other clear causes affecting male fertility: e.g., obstructive azoospermia, severe oligospermia (sperm concentration \<5×10⁶/mL), history of bilateral cryptorchidism surgery, genetic abnormalities (chromosomal anomalies such as Klinefelter syndrome, Y-chromosome microdeletions), severe reproductive tract damage, or infection history. (2) Spouse has significant infertility factors (e.g., bilateral tubal blockage, severe ovulation disorders) without effective treatment, which may severely impact pregnancy outcomes. (3) Previous bariatric surgery (e.g., gastric bypass, sleeve gastrectomy) or current use of other weight-loss medications (e.g., orlistat), or weight fluctuation \>5% within 3 months before enrollment. (4) Endocrine diseases affecting reproduction or sexual function: e.g., uncontrolled diabetes (HbA1c \>9%) or insulin-treated diabetes, clinically significant thyroid dysfunction, hyperprolactinemia. (5) Severe systemic diseases: Including significant cardiovascular diseases (unstable angina, class III-IV heart failure, etc.), active liver disease (transaminases \>2× upper limit of normal), severe renal impairment (eGFR \<30 mL/min/1.73m²), etc., making participation in clinical trials inappropriate. (6) History of acute pancreatitis; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) (GLP-1RA is contraindicated in these cases) ; or conditions unsuitable for weight-loss medications, such as severe hepatic/renal impairment or gallstones. (7) Use of GLP-1 receptor agonist therapy within the past 6 months. (8) Received other fertility-improving treatments within the past 6 months that cannot be discontinued (e.g., gonadotropins, clomiphene, testosterone preparations, or other drugs affecting semen such as exogenous testosterone or 5-alpha-reductase inhibitors). (9) Alcohol or drug abuse. (10) Psychiatric or cognitive disorders preventing cooperation with follow-up. (11) Any other condition deemed by the investigator to interfere with trial results or increase participant risk.

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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

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  1. The official record

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