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Feasibility RCT of tirzepatide plus digital weight‑management program versus behavior change alone in women with obesity and infertility

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 trial focuses on women who have both obesity and infertility. It tests whether adding the medication tirzepatide, given as a subcutaneous injection, to a weight‑management program delivered through a digital platform can help them lose weight and improve chances of pregnancy.

The main goal is to see if this combined approach is practical and acceptable for participants compared with the digital program alone. Participants are assigned by chance to one of two groups: one group receives weekly injections of tirzepatide together with access to the online program and monthly health‑coaching calls, while the other group uses only the online program and the same coaching without any medication.

All participants will attend study visits at about three, six and nine months after starting. During the visits their weight, waist size, blood pressure and blood tests are checked, and they answer questionnaires about diet, activity, mood and quality of life. The study also records how often participants use the app, attend coaching sessions and take the injections, with the aim of understanding whether the program can be used in future larger trials.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomisation and Group Assignment

    After you join the study, you will be randomly placed into one of two groups. One group receives the medication tirzepatide together with a digital weight‑management program, and the other group receives only the digital program.

    The randomisation process is performed by the study team and you will be informed of your group assignment without any influence from you.

  2. Step 2

    Baseline Assessments

    Before any intervention starts, you will attend a baseline visit where your weight, waist circumference, blood pressure, and body mass index (BMI) are measured.

    Blood samples will be taken to check glucose control (including HbA1c, a test that shows average blood sugar over the past three months), cholesterol, and other metabolic markers.

    You will also complete several questionnaires that assess your diet, physical activity, mental health (such as anxiety and depression), and quality of life.

  3. Step 3

    Digital Behaviour Change Program Setup

    You will receive login details for an online platform that delivers education, goal‑setting tools, and tracking features for diet and activity.

    The platform is accessible via a computer, tablet, or smartphone, and you will be shown how to record your meals, exercise, and weight each week.

  4. Step 4

    Medication Initiation (If Assigned to Medication Arm)

    If you are in the medication arm, you will start tirzepatide as a subcutaneous injection, meaning the drug is injected under the skin.

    The injection is given once a week using a pre‑filled pen. The starting dose is 2.5 mg per week.

    According to the study protocol, the dose may be increased stepwise (for example to 5 mg, 7.5 mg, 10 mg, 12.5 mg, and finally 15 mg) at set intervals, but you will only take the dose that your study clinician prescribes.

    You will continue the weekly injections for the duration of the trial, which lasts up to nine months.

  5. Step 5

    Monthly Health Coaching Sessions

    Throughout the first six months, you will have a health‑coaching call once each month. Up to six sessions are scheduled.

    During each session, the coach will review your progress on the digital platform, discuss any challenges, and help you set realistic goals for the next month.

    Attendance at at least four of the six sessions is considered acceptable engagement.

  6. Step 6

    Three‑Month Study Visit

    At three months after starting the trial, you will return for a follow‑up visit.

    Weight, waist circumference, and blood pressure will be measured again, and you will repeat the blood tests and questionnaires completed at baseline.

    The study team will also ask about your use of the digital platform and, if applicable, your adherence to the weekly tirzepatide injections.

  7. Step 7

    Six‑Month Study Visit

    At six months, a second follow‑up visit is scheduled.

    All measurements taken at the three‑month visit are repeated, and additional blood work is performed to assess metabolic changes.

    Your engagement with the digital program and health‑coaching sessions will be reviewed, and medication adherence will be evaluated (taking at least 75 % of prescribed doses is considered adherent).

  8. Step 8

    Nine‑Month Study Visit and Final Assessment

    The final visit occurs at nine months.

    Weight, waist circumference, blood pressure, and laboratory tests are repeated for the last time.

    You will complete the same set of questionnaires as at baseline to evaluate changes in diet, physical activity, mental health, and quality of life.

    If you are in the medication arm, you will stop the weekly tirzepatide injections after this visit.

  9. Step 9

    Optional Qualitative Interview

    A subset of participants from each group may be invited to take part in a semi‑structured interview.

    The interview explores your experience with the medication (if you received it) and the digital behaviour change program.

    Participation in the interview is voluntary and does not affect any other part of the trial.

Who can join the trial?

7 criteria

  • Be a woman who is between 18 and 39 years old.
  • Have a body mass index (BMI) between 30 and 40 kg/m² (BMI is a number that shows whether a person’s weight is in a healthy range for their height).
  • Have been trying to become pregnant for more than 12 months if you are younger than 36, or for more than 6 months if you are 36 or older, and have had fertility tests (checks to see how well your reproductive system is working) done within the last 6 months.
  • Meet the HSE criteria for fertility treatment (the specific health service requirements that allow you to receive fertility care).
  • Be willing to use a form of contraception (birth control) if you are placed in the group that receives the medication plus the digital program.
  • Fit all other study eligibility rules set by the researchers.
  • Be able and willing to give informed consent (understand the study and agree to take part).

Who cannot join the trial?

4 criteria

  • Current pregnancy or breastfeeding – you cannot be pregnant or feeding a baby while in the study.
  • Known hypersensitivity or contraindication to the study medication – this means you are allergic to the medicine or have a medical reason that makes using it unsafe.
  • Taking part in another drug trial at the same time – you cannot be enrolled in another study that tests a new medication while this study is happening. (You may still join studies that only observe without giving any treatment.)
  • Unwilling or unable to give informed consent – you must be able and willing to agree to join the study after understanding what it involves.
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Investigated drugs

Mounjaro is a medication that contains tirzepatide, a drug that helps lower blood sugar and can also reduce body weight. In this study participants receive it as a subcutaneous injection using a pre‑filled pen. The purpose is to see if adding this medication to a weight‑loss program helps women with obesity and infertility lose weight and improve their chances of becoming pregnant.

The digital behaviour change intervention is a weight‑management programme delivered through a smartphone or computer. It provides education, goal‑setting, tracking tools, and support to help participants change eating habits, increase physical activity, and adopt healthier lifestyles. In the trial it is used alone in one group and together with Mounjaro in another group to compare which approach works better.

What is already known about the treatment

Mounjaro - Mounjaro is a clear solution for injection that is delivered under the skin using a pre‑filled KwikPen. It contains tirzepatide, which is approved and commonly used to treat type 2 diabetes and to help adults lose weight. The drug works by activating two hormone receptors, GLP‑1 and GIP, which together lower blood sugar and reduce appetite, leading to weight loss. Pharmacologically it is classified as a dual GIP/GLP‑1 receptor agonist, an injectable glucose‑lowering medication.

Investigated diseases

  • Obesity

    Obesity is a condition where a person carries excess body fat that results in a body mass index of 30 kg/m² or higher. It develops gradually as energy intake consistently exceeds energy use. Without changes in diet or activity, the amount of fat usually continues to increase over time. This excess weight can affect many body systems and often makes losing weight more difficult as time goes on.

  • Infertility

    Infertility is the inability to achieve a pregnancy after at least one year of regular, unprotected sexual intercourse. It can result from problems with ovulation, the uterus, fallopian tubes, or other factors. If the underlying cause is not addressed, the condition may persist for months or years. It often leads to irregular menstrual cycles or other signs that indicate reproductive challenges.

Trial detailsLast updated 2 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526869-19-00Protocol codeCRC.0062Estimated enrolment60 patientsSponsorUniversity College Dublin

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