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A study to evaluate the efficacy and safety of MET097 in people with obesity or overweight.

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What is this trial about?

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

This study focuses on individuals living with Obesity, which is a medical condition characterized by an excessive amount of body fat. The research aims to evaluate the effectiveness and safety of a medication known as MET097. This treatment is a type of GLP-1RA, which is a class of drugs that mimics a natural hormone in the body to help regulate appetite and blood sugar levels. The medication is administered as a subcutaneous injection, meaning it is delivered via a needle into the fatty tissue just under the skin.

Participants in this study will be assigned to receive either MET097 or a placebo. The study is designed to compare how much body weight changes over a specific period of time. During the course of the trial, individuals will receive their assigned treatment once every week. The process involves monitoring weight changes and other health factors over a long period, extending up to 84 weeks, to observe the impact of the medication on overall health.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and medication administration

    You will receive either the test medication (met097) or a placebo, which is a substance that contains no active medicine. the assignment to a specific group is determined by chance.

    If assigned to the test medication, it is administered as a subcutaneous injection, which means the medicine is injected into the fatty tissue just under the skin. the dose is 5mg/ml.

    The medication is administered once weekly.

    The study lasts for a total of 64 weeks to evaluate the effectiveness and safety of the treatment regarding body weight changes.

  2. Step 2

    Extended follow-up

    After the initial 64 weeks, measurements of body weight are continued until week 84 to observe long-term results.

Who can join the trial?

10 criteria

  • You must be able to sign and date a consent form, which is a document that explains the study and shows you agree to participate.
  • You must be an adult, at least 18 years old.
  • You must have a Body Mass Index (BMI), which is a way to measure if your weight is healthy for your height, of 30 or higher.
  • Alternatively, you may join if your BMI is between 27.0 and 30.0 and you have at least one of the following health conditions related to weight:
  • Hypertension, which is high blood pressure, either while taking regular medication or having a reading of 130/80 or higher.
  • Dyslipidemia, which means having unhealthy levels of fats in your blood, such as high LDL cholesterol (often called "bad" cholesterol), high triglycerides (a type of fat in the blood), or low HDL cholesterol (often called "good" cholesterol).
  • Obstructive sleep apnea, a condition where your breathing repeatedly stops and starts while you sleep.
  • Cardiovascular disease, which refers to various heart and blood vessel problems, such as heart failure, history of a stroke (when blood flow to the brain is blocked), myocardial infarction (a heart attack), coronary artery disease (narrowed heart arteries), or peripheral vascular disease (blood vessel problems in the arms or legs).
  • You must be willing and able to self-inject the study medicine, which means giving yourself a shot, or have a trained family member or caregiver do it for you if you have vision or physical limitations.
  • You must be willing to follow the study rules for the entire time, including following lifestyle advice like specific eating plans and exercise routines, and completing all required forms and surveys.

Who cannot join the trial?

7 criteria

  • Women who are currently breastfeeding or who are pregnant at the start of the study or before the first dose.
  • People who are unwilling or unable to follow the rules regarding contraception, which are methods used to prevent pregnancy.
  • People with a low estimated glomerular filtration rate (eGFR), which is a measurement used to check how well the kidneys are filtering waste from the blood. A level below 30 mL/min/1.73 m2 means the kidneys are not working well enough.
  • People with abnormal thyroid-stimulating hormone (TSH) levels, which is a hormone that tells the thyroid gland how much hormone to make. The level must not be lower than 0.4 mIU/L or higher than 6.0 mIU/L, unless the person has been on a stable dose of thyroid medication for at least 3 months.
  • People with poorly controlled hypertension, which is a medical term for high blood pressure that is not managed well. This is defined as having a top number (systolic) of 180 mm Hg or higher, or a bottom number (diastolic) of 120 mm Hg or higher.
  • People diagnosed with diabetes, which is a condition where blood sugar levels are too high. This includes anyone with an HbA1c (a 3-month average of blood sugar levels) of 6.5% or higher, fasting glucose (blood sugar after not eating) of more than 125 mg/dL, or random glucose (blood sugar at any time) of 200 mg/dL or higher accompanied by symptoms of high blood sugar.
  • People who have taken any medications to lower glucose (blood sugar) within the 90 days before the start of the study.
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Investigated drugs

MET097 is an injection used to help with weight management. It belongs to a class of medicines that mimic a natural hormone in the body to help control appetite and regulate weight in people who are overweight or living with obesity.

What is already known about the treatment

  • MET097

    This medication is an injectable solution administered once a week through a small needle under the skin. Currently being studied in late-stage clinical trials, it is being developed as a treatment to help people manage weight by addressing obesity. It belongs to a class of drugs called GLP-1 receptor agonists, which work by mimicking a natural hormone in the body to signal the brain to feel full and slow down digestion.

  • Placebo

    This is an inactive substance that looks exactly like the study medication but contains no active medicinal ingredients. It is administered via the same injection method as the test drug to ensure the study results are accurate and unbiased. In clinical research, the placebo serves as a control to help scientists determine if the effects seen in patients are truly caused by the new medication.

Investigated diseases

Obesity - This condition involves the accumulation of excess body fat to an extent that it may impact health. It typically develops when a person consumes more calories than their body uses for energy over an extended period. The process often involves an increase in adipose tissue, which is the body's primary storage for fat. As the condition progresses, the amount of stored fat continues to rise, affecting body composition. It can be influenced by various factors including diet, physical activity levels, and biological processes.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523974-18-00Protocol codeMET097-25-301Estimated enrolment3 500 patientsSponsorMetsera Inc.

sourced from the EU Clinical Trials Register and site verification

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