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A Phase III Study of Once‑Weekly Petrelintide to Evaluate Efficacy and Safety for Weight Loss in Adults with Overweight or Obesity

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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 adults who have overweight or obesity, a condition where excess body fat can increase the risk of health problems. Participants will receive a once‑weekly subcutaneous injection of the investigational drug petrelintide or a matching placebo. The purpose of the study is to evaluate how well petrelintide works compared with placebo in reducing body weight.

After enrollment, individuals are randomly assigned to receive either petrelintide or the placebo, and neither the participants nor the study staff know which treatment is given. Injections are administered under the skin once each week for a period of about 64 weeks. Throughout the study, participants attend regular clinic visits where simple measurements such as weight, waist size, and blood pressure are taken, and blood samples are collected to check safety and how the body is responding.

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

    Randomization and Assignment

    After joining the study, you will be randomly assigned to receive either petrelintide or a matching placebo. The assignment is unknown to you and the study staff (double‑blind).

  2. Step 2

    Baseline Assessments

    Before the first injection, a series of measurements will be taken, including your body weight, waist circumference, blood pressure, and a blood sample for laboratory tests.

    An electrocardiogram (ECG) will be performed to record the electrical activity of your heart.

    These baseline values will be used to compare changes that occur during the study.

  3. Step 3

    First Injection

    You will receive a single subcutaneous injection (injection under the skin) of the assigned study drug.

    The injection volume is 0.25 mL for petrelintide and 0.75 mL for the placebo. The exact dose is defined by the study protocol.

  4. Step 4

    Weekly Injections

    You will administer one injection each week for the next 64 weeks.

    Injections may be given at the clinic or at home, following the instructions provided by the study team.

    Each injection uses the same volume and route as the first dose.

  5. Step 5

    Periodic Clinic Visits

    Every four weeks you will attend a clinic visit where your weight, waist circumference, and vital signs will be measured.

    Blood samples will be taken to monitor safety laboratory values such as glucose, cholesterol, and liver function.

    An ECG may be repeated at selected visits to check heart health.

  6. Step 6

    Safety Monitoring

    Throughout the study you will be asked about any adverse events, including symptoms that may be mild, moderate, or severe.

    If an adverse event occurs, the study staff will assess whether it is related to the study drug and decide if any action is needed.

  7. Step 7

    Final Assessment at Week 64

    At the end of week 64, a comprehensive evaluation will be performed.

    Measurements will include body weight, waist circumference, blood pressure, and a full set of laboratory tests.

    Blood will be collected to measure petrelintide levels and to test for anti‑drug antibodies.

    An ECG will be done one last time.

  8. Step 8

    Study Completion

    After the final assessment, you will stop receiving the study injections.

    A final safety review will be conducted, and you will be informed about any follow‑up that may be recommended.

Who can join the trial?

5 criteria

  • Be able and willing to follow all study steps, such as attending visits, filling out questionnaires, and completing required tests.
  • Be 18 years old or older when you sign the consent form.
  • Have a BMI of 30 or higher, or a BMI of 27 or higher if you also have at least one health problem linked to weight (for example, high blood pressure, diabetes, or sleep apnea). BMI stands for body mass index and is a number that compares your weight to your height.
  • Have tried at least one diet or eating plan on your own that did not lead to lasting weight loss.
  • Agree to use birth control methods (contraception) as required during the study. Contraception means any method used to prevent pregnancy.

Who cannot join the trial?

3 criteria

  • Having a blood test called glycated hemoglobin (HbA1c) that shows a level of 48 mmol/mol (6.5%) or higher, which means the average blood sugar is in the diabetic range.
  • Having a known history of type 1 or type 2 diabetes mellitus, which are conditions where the body cannot properly control blood sugar.
  • Having taken or currently taking petrelintide or any other amylin analog, which are medicines that act like a hormone that helps regulate blood sugar.
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Investigated drugs

Petrelintide is the investigational medicine being tested in this study. It is given as a liquid that is injected under the skin once a week. The drug is being examined to see if it can help people who are overweight or obese lose body weight. Researchers will watch participants for changes in weight and also check for any side effects while they receive the medication.

What is already known about the treatment

Petrelintide - Petrelintide is given as a subcutaneous injection in a clear solution for injection, typically once weekly. It is an experimental peptide currently being studied in clinical trials and is not yet approved for any medical use. The drug is intended to help people who are overweight or obese lose weight. It works by mimicking a natural hormone that reduces appetite and increases the body’s use of energy, and it is classified as a peptide analog that acts like a GLP‑1 receptor agonist.

Investigated diseases

Overweight or obesity - Overweight or obesity is a condition in which a person carries excess body weight relative to height, typically measured by a body mass index of 25 kg/m² or higher. The condition can develop gradually as energy intake consistently exceeds energy expenditure, leading to accumulation of fat tissue. Over time, individuals may progress from overweight (BMI 25–29.9) to obesity (BMI ≥ 30), with increasing amounts of adipose tissue. The excess weight can expand abdominal circumference and increase fat deposits in various body regions. As the condition advances, metabolic changes such as higher insulin levels and altered lipid profiles may become more pronounced.
Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-526188-39-00Protocol codeCC46368Estimated enrolment3 497 patientsSponsorF. Hoffmann-La Roche AG

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