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Effect of Semaglutide on Sperm Concentration in Overweight Infertile Men: A Randomized Placebo‑Controlled Trial

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on men who have difficulty conceiving (Infertility) and who are also classified as overweight. The medication being tested is a weekly injection called semaglutide, delivered with a pre‑filled pen that places the dose under the skin (subcutaneous). A matching pen that contains no active drug (placebo) is used for comparison.

The purpose is to determine whether the medication changes the number of sperm produced, measured as sperm concentration, compared with the placebo. Participants receive an injection once a week for several months and attend a few clinic visits where blood samples, body measurements and semen samples are collected to evaluate sperm count, hormone levels and other health markers. No surgery is involved, and the follow‑up period lasts about six months.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline visit and randomization

    On the first day in the study you attend a baseline visit where a sperm sample, blood tests, weight, body mass index (bmi), and body composition scan (dxa) are performed. questionnaires about symptoms of androgen deficiency and sexual function are also completed.

    After the assessments you are randomly assigned to receive either semaglutide 2.4 mg or a placebo. you are given a pre‑filled pen and instructions on how to give a subcutaneous injection (injection under the skin).

  2. Step 2

    Start weekly injections

    Starting on the day of randomization you inject 2.4 mg of the assigned product once a week using the pen. the injection is given under the skin of the abdomen or thigh.

    You continue the weekly injections for the entire study period, which lasts until day 300 (about ten months). the schedule is the same for both the active drug and the placebo.

  3. Step 3

    First follow‑up visit (day 100)

    Approximately three months after the first injection you return for a follow‑up visit. a new sperm sample is collected and analyzed for concentration and total count.

    Blood tests are repeated to measure testosterone, luteinizing hormone (lh), follicle‑stimulating hormone (fsh), and other hormones. weight, bmi, and questionnaires are updated.

    The study staff checks your injection technique, reviews any side effects, and confirms that you are continuing the weekly injections.

  4. Step 4

    Second follow‑up visit (day 200)

    Around six months after starting treatment you attend the second follow‑up. the primary outcome of the study – sperm concentration and total sperm count – is measured again.

    Additional blood tests assess hormone levels, cholesterol, hbA1c, and insulin resistance (homa‑ir). weight, bmi, and questionnaires are repeated.

    The weekly injection schedule remains unchanged.

  5. Step 5

    Final follow‑up visit (day 300)

    At about ten months you complete the final visit. a comprehensive sperm analysis is performed, including dna fragmentation index and evaluation of motility, morphology, and total motile sperm.

    A dxa scan evaluates body composition, total body fat, muscle mass, bone mineral density (bmd), and trabecular bone score (tbs).

    Blood tests again measure testosterone, lh, fsh, sex hormone‑binding globulin (shbg), estradiol, amh, inhibin b, cholesterol fractions, hbA1c, and homa‑ir.

    Questionnaires on androgen deficiency and sexual function are completed for the last time.

  6. Step 6

    Study completion

    After the day 300 visit the study drug is stopped. you return any remaining pens and receive information about the study results when they become available.

    No further study‑specific visits are required unless a separate follow‑up is arranged by your health care provider.

Who can join the trial?

6 criteria

  • You must sign a written agreement called informed consent that shows you understand the study before any study procedures are done; this document explains the study and records your permission to take part.
  • You must be a man who is between 18 and 60 years old when you sign the consent form.
  • You must have infertility and at least one of the following sperm test results:
    • Sperm concentration (the number of sperm in each milliliter of semen) less than 16 million.
    • Less than 42% of sperm that can move, called motile spermatozoa.
    • Less than 4% of sperm that look normal in shape, called morphologically normal spermatozoa.
    • Your body mass index, known as BMI, must be 27 or higher; BMI is a calculation using your height and weight to show if you are overweight.

Who cannot join the trial?

20 criteria

  • Having Type 1 diabetes, a condition where the body cannot produce insulin.
  • Being overweight because of hormone problems such as Cushing’s syndrome, which causes excess cortisol.
  • Taking any prescription or over‑the‑counter medicine (other than routine vitamins, occasional paracetamol, aspirin, or ibuprofen) that could affect how the study drug is absorbed, moves, or works in the body (pharmacokinetic or pharmacodynamic effects).
  • Having a past history of pancreatitis, which is inflammation of the pancreas.
  • Using morphine every day, a strong pain medication.
  • Having surgery planned during the study period, except for very small procedures that do not involve the stomach or intestines.
  • Having previously undergone bariatric surgery, a type of weight‑loss surgery.
  • Having any current or past cancer (except common skin cancers called basal cell skin cancer or squamous cell skin cancer) that could affect the study results.
  • Being unable or unwilling to give yourself an injection during the screening visit with a test pen (self‑injection).
  • Having mental or language difficulties, or being unwilling to follow the study rules, that would prevent proper understanding or cooperation (mental incapacity or language barriers).
  • Having poorly controlled type 2 diabetes as judged by the doctor.
  • Having a total sperm count higher than 80 million per milliliter (total sperm count >80 mio/mL).
  • Having a low blood level of the hormone FSH (less than 2 IU/L).
  • Having a very low sperm concentration (less than 1 million per milliliter, sperm concentration < 1 mio/mL).
  • Having a body‑mass index (BMI) greater than 50 kg/m², indicating severe obesity.
  • Having reduced kidney function with an estimated glomerular filtration rate (GFR) below 45 ml/min/1.73 m².
  • Having known chromosome problems (chromosomal aberrations) except for small deletions on the Y chromosome.
  • Having a detected mutation in the CFTR gene, which is linked to cystic fibrosis.
  • Having used a GLP‑1RA (a diabetes medication that activates the GLP‑1 receptor) within the past 6 months.
  • Having any other health condition that the doctor believes could make participation unsafe or difficult to follow.
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Investigated drugs

Semaglutide is a medication given as an injection under the skin once a week. It works like a natural hormone that helps control blood sugar and can also reduce appetite, leading to weight loss. In this trial, the drug is being studied to see if it can improve sperm concentration in overweight men who have difficulty conceiving.

What is already known about the treatment

Semaglutide - Semaglutide is supplied as a solution for injection in a pre‑filled pen and is given under the skin once a week. It is an approved medicine that is widely used for weight management and type 2 diabetes and is well documented in medical literature. It is mainly prescribed to help overweight people lose weight and to improve blood sugar control. It works by copying a natural hormone that tells the brain to eat less and slows the emptying of the stomach, which reduces appetite. It belongs to the drug class called GLP‑1 receptor agonists.

Investigated diseases

  • Infertility

    Infertility is the inability to achieve a pregnancy after at least one year of regular, unprotected sexual intercourse. In men, it commonly reflects reduced sperm production, poor sperm quality, or problems with sperm delivery. The condition may develop gradually as hormonal or genetic factors, health issues, or lifestyle influences affect testicular function. As the underlying cause persists, sperm count and other parameters can continue to decline over time.

  • Overweight

    Overweight describes a body weight that exceeds the healthy range for a given height, typically defined by a body‑mass index of 25–29.9 kg/m². It usually results from a gradual surplus of calories over energy expenditure, leading to increased fat stores. Over time, excess weight can accumulate further and affect metabolism and organ function. If lifestyle patterns remain unchanged, the amount of body fat may continue to rise.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-527538-29-00Estimated enrolment150 patientsSponsorRigshospitalet

sourced from the EU Clinical Trials Register and site verification

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