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Phase III Study Evaluating Efficacy and Safety of Petrelintide in Participants with Overweight or Obesity and Established Cardiovascular Disease

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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 individuals who have Overweight or Obesity together with Cardiovascular Disease. The medication being tested is Petrelintide, which is given as a subcutaneous injection once a week. Some participants will receive a harmless substance called placebo instead of the active drug, allowing researchers to compare the outcomes.

The purpose of the study is to determine whether weekly Petrelintide helps participants lose weight compared with placebo over about 64 weeks. Participants will attend regular clinic visits where their weight, waist circumference, and BMI will be measured, and blood samples will be taken to check levels of hsCRP (a marker of inflammation), triglycerides (a type of blood fat), HDL cholesterol (the “good” cholesterol), and LDL cholesterol (the “bad” cholesterol) as well as other metabolic markers. Safety will be monitored by checking blood pressure, performing an ECG (a test that records the heart’s electrical activity), and recording any side effects that occur during the study period.

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

    Randomization and Baseline Assessments

    After joining the study, you will be assigned randomly to receive either petrelintide or a matching placebo. The assignment is concealed, so neither you nor the study staff will know which product you receive.

    A series of baseline measurements will be taken, including body weight, waist circumference, blood pressure, and blood samples for laboratory tests such as cholesterol, triglycerides, fasting glucose, and markers of inflammation.

  2. Step 2

    Start of Weekly Injections

    You will begin receiving a subcutaneous injection (injection under the skin) once each week. The exact amount of petrelintide or placebo is specified by the study protocol and is administered in a pre‑filled syringe.

    Injections are given at the study site or, if allowed by the protocol, you may be trained to self‑administer the injection at home.

  3. Step 3

    Ongoing Weekly Visits and Monitoring

    Each week you will attend a visit (or a remote check‑in if permitted) to receive the next injection and to report any side effects or health changes.

    At regular intervals—typically every 4 to 8 weeks—additional measurements will be recorded, including body weight, waist circumference, and blood pressure.

    Blood samples will be collected periodically to monitor cholesterol levels, triglycerides, high‑density lipoprotein (HDL) cholesterol, low‑density lipoprotein (LDL) cholesterol, very‑low‑density lipoprotein (VLDL) cholesterol, non‑HDL cholesterol, total cholesterol, fasting insulin, fasting glucose, hemoglobin A1c (HbA1c), high‑sensitivity C‑reactive protein (hsCRP), and free fatty acids.

  4. Step 4

    Safety Laboratory Tests and ECGs

    Throughout the treatment period, safety laboratory values (such as liver and kidney function tests) and vital signs will be checked at the study visits.

    An electrocardiogram (ECG) may be performed to assess heart rhythm and function.

  5. Step 5

    Week 64 Final Efficacy Evaluation

    After 64 weeks of weekly injections, a comprehensive assessment will be performed. Your body weight will be measured to determine the percent change from the baseline value.

    Additional outcomes evaluated at this time include the proportion of participants who have lost at least 5%, 10%, or 15% of their initial body weight, changes in waist circumference, waist‑to‑hip ratio, waist‑to‑height ratio, body‑mass index (BMI), and all laboratory parameters listed above.

    The occurrence of any cardiovascular events, adverse events, and the presence of anti‑drug antibodies against petrelintide will also be recorded.

  6. Step 6

    Study Completion and Follow‑Up

    At the end of the study, you will discontinue the study medication and may have a final safety visit to ensure that any lingering side effects are addressed.

    You may be asked to provide a final blood sample to measure the concentration of petrelintide in the body and to check for any new anti‑drug antibodies.

Who can join the trial?

5 criteria

  • Have a body mass index (BMI) of 27 or higher (BMI is a number that compares your weight to your height).
  • Be at least 40 years old when you sign the Informed Consent Form (a document that explains the study and your rights).
  • Be able and willing to follow all study instructions, attend visits, fill out questionnaires, and complete any tests for the whole study period.
  • Have tried at least one diet plan that did not help you lose weight, as you remember.
  • Agree to follow the study’s birth‑control (contraception) rules, which help prevent pregnancy during the trial.

Who cannot join the trial?

1 criterion

  • You cannot join the study if you have already taken petrelintide (the medication being tested) or any other amylin analog (a drug that mimics a natural hormone called amylin, which helps control blood sugar and appetite).
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Investigated drugs

Petrelintide (RO7895515) is a medication that is given as a liquid injection under the skin once a week. It is being tested to see if it can help people who are overweight or have obesity lose weight. In this study, participants who also have established cardiovascular disease will receive the injection and be monitored for changes in their body weight over 64 weeks. Researchers will also watch for safety and any possible side effects while the medication is used.

What is already known about the treatment

Petrelintide - Petrelintide is given as a clear solution for injection that is administered under the skin once a week. It is still an investigational drug, currently being studied in Phase III trials and not yet approved for general medical use. The drug is being tested to help people who are overweight or obese and have heart disease lose weight and improve heart health. It works by acting like a natural hormone that tells the brain to feel full and helps the body use sugar and fat more efficiently, and it belongs to the class of peptide hormone analogs that activate the GLP‑1 receptor.

Investigated diseases

  • Overweight or Obesity

    a condition in which a person carries excess body weight, usually identified by a high body‑mass index. It develops when more calories are consumed than are burned, leading to increased fat storage. Over time, the extra weight makes the body work harder and can affect metabolism and organ function. If lifestyle habits remain unchanged, the amount of excess weight may continue to rise. The condition can persist for many years.

  • Established Cardiovascular Disease

    refers to individuals who already have disease of the heart or blood vessels, such as a prior heart attack, stroke, or peripheral artery disease. These conditions arise when plaque builds up in arteries, narrowing the passage for blood. Reduced blood flow can cause damage to the heart muscle or other organs over time. The disease may progress silently as blockages become larger. Ongoing narrowing can lead to additional cardiovascular events if the underlying process continues.

Trial detailsLast updated 12 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526190-41-00Protocol codeCC46446Estimated enrolment2 050 patientsSponsorF. Hoffmann-La Roche AG

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