Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Efficacy and Safety of MET097 Once Weekly in People with Overweight or Obesity and Type 2 Diabetes

Fast replyInvestigational
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

The trial focuses on adults who have obesity together with type 2 diabetes. The experimental medicine being tested is MET097, which is administered as a subcutaneous injection once each week, and it is compared with a matching placebo. Participants will be randomly placed into one of the two groups, and both groups will receive weekly injections for the duration of the study.

The purpose of the study is to see if MET097 helps participants lose more weight than the placebo after about 64 weeks. Throughout the trial, participants will visit the clinic regularly for weight checks, safety assessments, and blood tests, including a measurement of HbA1c, a test that shows the average blood‑sugar level over the past two to three months. Additional evaluations will monitor changes in cholesterol, blood pressure, and overall health status, and the study will continue with follow‑up visits for up to roughly 84 weeks.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    After joining the study, a consent form is completed and basic health information is recorded.

    The information is reviewed to confirm eligibility for the trial.

  2. Step 2

    Baseline assessment

    A baseline visit is scheduled within the first two weeks of enrollment.

    During this visit, weight, blood pressure, blood samples for hbA1c and other laboratory tests, and a health questionnaire are collected.

    The results create a reference point for all future measurements.

  3. Step 3

    Randomization

    After the baseline assessment, you are randomly assigned to receive either met097 or a placebo injection.

    The assignment is unknown to you and the study staff who interact with you.

  4. Step 4

    Start of weekly injections

    The first injection is administered at the baseline visit.

    The injection is a subcutaneous (under the skin) dose of met097 solution for injection, 5 mg/mL, given once each week.

    If assigned to the placebo group, an inactive injection of the same appearance is given on the same schedule.

  5. Step 5

    Regular follow‑up visits

    Clinic visits occur at regular intervals (for example, weeks 4, 12, 24, 36, 64, and 84).

    At each visit, weight, blood pressure, and a short health questionnaire are recorded.

    Blood samples are taken to measure hbA1c, fasting triglycerides, non‑hdl‑c, and other safety labs.

    Any side effects or concerns are reviewed and documented.

  6. Step 6

    Primary efficacy evaluation

    At week 64, the primary outcome (percent change in body weight from baseline) is calculated.

    Additional measurements of weight, hbA1c, blood pressure, and laboratory values are compared with baseline values.

  7. Step 7

    Extended treatment period

    After the week‑64 evaluation, weekly injections continue for an additional 20 weeks, ending at week 84.

    Follow‑up visits continue as described in step 5.

  8. Step 8

    Final assessment and study completion

    At week 84, final measurements of weight, hbA1c, blood pressure, and laboratory tests are performed.

    The study medication is discontinued after the final dose.

    All collected data are used for the final analysis of safety and efficacy.

Who can join the trial?

7 criteria

  • Provide a signed and dated informed consent form, showing you agree to join the study.
  • Be an adult (male or female) who is 18 years old or older.
  • Have a BMI of 27 or higher at the screening visit. BMI (body mass index) is a number that compares your weight to your height.
  • Have type 2 diabetes (high blood sugar) for at least 6 months before the screening, based on your own report or medical records.
  • Show a HbA1c test result between 6.5% and 10.0% at screening and have been on a stable diabetes treatment for at least 90 days. HbA1c measures your average blood sugar level over the past 2–3 months.
  • Be treated for diabetes with diet and exercise alone or with oral medicines, but not with DPP-4 inhibitors (a class of pills that lower blood sugar). You must NOT be taking GLP-1 agonists (injection medicines that lower blood sugar) or insulin (a hormone given by injection to control blood sugar).
  • Be motivated, able, and willing to self‑inject the study drug (or have a trained family member or caregiver give the injection if you have vision or physical difficulties), check your blood sugar by a finger‑stick test (including a weekly fasting glucose measurement), follow the lifestyle advice (such as diet and exercise plans), and complete the required paperwork and questionnaires.

Who cannot join the trial?

8 criteria

  • Being a female who is breastfeeding or pregnant at the time of screening or becomes pregnant before the study starts.
  • Being unwilling or unable to follow the required birth‑control (contraceptive) rules.
  • Having Type 1 diabetes or any other form of diabetes besides Type 2 diabetes.
  • Having had diabetic ketoacidosis (a serious condition where the body makes too many acids) or a hyperosmolar state (a very high‑blood‑sugar emergency) within the past year.
  • Having experienced severe low blood sugar (hypoglycemia) or not feeling the warning signs of low blood sugar in the past six months.
  • Having a kidney‑function test called estimated glomerular filtration rate (eGFR) that is lower than 30 mL/min/1.73 m² (this test measures how well the kidneys filter waste).
  • Having a blood test for thyroid‑stimulating hormone (TSH) that is below 0.4 or above 6.0 (TSH checks how well the thyroid gland is working). Participants on stable thyroid medicine may be allowed.
  • Having very high blood pressure at screening, defined as a seated systolic pressure of 180 mm Hg or higher, or a diastolic pressure of 120 mm Hg or higher.
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

MET097 is an experimental injectable medicine that works by activating the GLP‑1 receptor in the body. It is designed to stay active for a long time, so it can be given once a week under the skin. In this study, the drug is being tested to see if it can help people who have overweight or obesity together with type‑2 diabetes lose weight and improve their blood sugar control.

What is already known about the treatment

MET097 Injection - MET097 is supplied as a clear solution for subcutaneous injection, given under the skin once a week. It is currently an investigational medication in Phase 3 clinical trials and has not yet received marketing approval. The drug is aimed at treating obesity and type 2 diabetes by acting as an ultra long‑acting GLP‑1 receptor agonist, which helps lower blood sugar and reduces appetite. Pharmacologically, it belongs to the class of peptide‑based GLP‑1 receptor agonists that specifically target the GLP‑1 hormone pathway.

Investigated diseases

Obesity - Obesity is a condition where a person carries an excess amount of body fat. It usually develops over time as calorie intake consistently exceeds energy use. As weight increases, the body may become less able to move easily and may feel more tired during daily activities. The accumulation of fat often spreads to different parts of the body, making clothing feel tighter and affecting physical comfort. Continued weight gain can further reduce mobility and increase strain on joints.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523975-48-00Protocol codeMET097-25-302Estimated enrolment999 patientsSponsorMetsera Inc.

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.