Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Tirzepatide and Semaglutide for Weight Loss in Adults with Obesity or Overweight and Related Health Issues

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the effects of a medication called Tirzepatide (also known by its code name LY3298176) in adults who have obesity or are overweight with additional health issues related to their weight. The study will compare Tirzepatide to another medication called Semaglutide, which is also used to help with weight loss. Both medications are given as a solution for injection.

The purpose of the study is to see if Tirzepatide is more effective than Semaglutide in helping participants lose weight. Participants will receive either Tirzepatide, Semaglutide, or a placebo over a period of time. The study will monitor changes in body weight, waist size, and body mass index (BMI), which is a measure of body fat based on height and weight. The study will also look at how many participants achieve significant weight loss, such as losing 10% or more of their body weight.

Participants will be involved in the study for up to 72 weeks, during which they will receive regular injections and attend follow-up visits to track their progress. The study aims to provide valuable information on the effectiveness and safety of Tirzepatide compared to Semaglutide for weight management in individuals with obesity or overweight conditions.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on criteria such as having obesity or being overweight with conditions like high blood pressure or high cholesterol.

    You will receive detailed information about the study, including the medications involved and the procedures you will undergo.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either tirzepatide or semaglutide. This means you will not choose which medication you receive, and neither will the study staff.

    This process ensures that the study results are unbiased and reliable.

  3. Step 3

    Medication administration

    You will receive your assigned medication as a solution for injection. The medication will be administered under the skin, similar to how insulin is given.

    If you are assigned semaglutide, you will receive a dose of 2.4 mg once a week. If you are assigned tirzepatide, the dose will be determined based on the maximum tolerated dose (MTD) for you.

  4. Step 4

    Regular follow-up visits

    You will attend regular follow-up visits throughout the study. These visits are important for monitoring your health and the effects of the medication.

    During these visits, your weight, waist circumference, and other health indicators will be measured to track changes from the start of the study.

  5. Step 5

    End of study

    The study is expected to end by September 30, 2024. At the end of the study, you will have a final visit where all necessary assessments will be completed.

    The results of the study will help determine the effectiveness and safety of tirzepatide compared to semaglutide in achieving weight loss.

Who can join the trial?

6 criteria

  • Must have obesity.
  • Must have overweight with at least one of the following conditions:
    • Obstructive sleep apnea (a condition where breathing stops and starts during sleep)
    • High blood pressure (also known as hypertension)
    • High cholesterol (high levels of fats in the blood)
    • Heart disease (any disorder that affects the heart)
    • Open to both male and female participants.

Who cannot join the trial?

10 criteria

  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients with uncontrolled high blood pressure, which means their blood pressure is not well-managed with medication or lifestyle changes.
  • Patients with a history of heart attack or stroke within the last 6 months.
  • Patients with severe kidney disease, which means their kidneys are not working well.
  • Patients with severe liver disease, which means their liver is not functioning properly.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of certain types of cancer, except for skin cancer that is not melanoma.
  • Patients with a history of drug or alcohol abuse within the last year.
  • Patients who are unable to follow the study procedures or attend the required visits.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Tirzepatide

    is a medication being studied for its ability to help people lose weight. It works by mimicking certain hormones in the body that help control blood sugar levels and appetite. This medication is being tested to see if it can help people with obesity or who are overweight to lose weight more effectively than other treatments.

  • Semaglutide

    is another medication used in this study, which is already known to help with weight loss. It works by helping to regulate appetite and food intake, making people feel fuller after eating. This medication is being compared to tirzepatide to see which one is more effective in helping people lose weight.

What is already known about the treatment

  • Tirzepatide

    Tirzepatide is administered as an injection under the skin, typically once a week. It is currently being studied in clinical trials to assess its effectiveness and safety for weight loss in adults who are obese or overweight with related health issues. The main purpose of this medication is to help reduce body weight. At the molecular level, Tirzepatide works by mimicking hormones that regulate appetite and insulin levels, helping to control hunger and blood sugar. It is classified as a dual agonist, targeting specific receptors involved in these processes.

  • Semaglutide

    Semaglutide is also given as an injection under the skin, usually once a week. It is already approved for use in managing obesity and overweight conditions, especially in individuals with weight-related health problems. The primary goal of Semaglutide is to aid in weight loss. It functions by imitating a hormone that influences appetite and insulin secretion, which helps to reduce hunger and manage blood sugar levels. Semaglutide is classified as a GLP-1 receptor agonist, focusing on receptors that play a role in these bodily functions.

Investigated diseases

  • Obesity

    Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when calorie intake consistently exceeds calorie expenditure, leading to an energy imbalance. Over time, this imbalance results in the storage of excess energy as fat. The progression of obesity can lead to increased body mass index (BMI) and waist circumference. As the condition advances, it may contribute to the development of related health issues. Obesity is often measured by BMI, with a BMI of 30 or higher indicating obesity.

  • Overweight

    Overweight is a condition where an individual has more body weight than is considered healthy for their height. It occurs when there is an imbalance between calories consumed and calories expended, leading to excess body weight. This condition is often assessed using the body mass index (BMI), with a BMI between 25 and 29.9 indicating overweight. Over time, being overweight can lead to increased fat accumulation and changes in body composition. The progression of overweight can increase the risk of developing obesity and related health conditions. Monitoring weight and waist circumference can help track changes in this condition.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501106-35-00Protocol code17203Estimated enrolment700 patientsSponsorEli Lilly & Co.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.