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Zenagamtide for Weight Loss in Adults with Obesity

Fast replyInvestigationalNo placebo
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What is this trial about?

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

This clinical trial is studying obesity, a condition in which a person has too much body fat and may have health problems because of it. The treatment being tested is zenagamtide, given once a week as a shot under the skin, using a pre-filled pen. Several different dose levels of NNC0487-0111 are being compared with placebo to see which works best.

The purpose of the study is to see how well NNC0487-0111 helps people with obesity lose weight and to check its safety. People in the trial will receive weekly treatment over a period of time, and the study will follow changes in body weight and other health measures during the trial. The study may also look at body size, blood pressure, blood sugar, blood fats, and signs of inflammation, as well as any side effects.

The trial is designed to compare different amounts of the study medicine with placebo, and some people may continue into an extension phase, which means treatment and follow-up may last longer. The overall study is planned to run for several years.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study treatment start</b>

    After joining the study, you start receiving one of the study treatments: placebo or zenagamtide (the study medicine in NNC0487-0111).

    The medicine is given as a subcutaneous injection, which means an injection under the skin, using a pre-filled pen.

    The treatment is given once weekly.

    The study compares several dose levels of NNC0487-0111 against placebo. The source data lists the dose as 0 with the unit other, but does not provide a readable dose amount.

  2. Step 2

    <b>during the treatment period</b>

    You continue with the assigned once-weekly injection for the study period.

    Your body weight is checked to see how much it changes over time.

    Your waist size is measured.

    Your blood pressure is measured, including systolic blood pressure (SBP) and diastolic blood pressure (DBP). Systolic blood pressure is the upper number in a blood pressure reading, and diastolic blood pressure is the lower number.

    Your blood is tested for HbA1c, which shows average blood sugar levels over time, fasting plasma glucose (FPG), which is blood sugar after not eating, and fasting insulin.

    Your blood is also tested for lipids, which are blood fats, including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, non-HDL cholesterol, and triglycerides.

    Your blood is tested for hsCRP, which means high-sensitivity C-reactive protein, a marker of inflammation.

    You complete questionnaires about how your weight affects your daily life and physical function, including the IWQOL-Lite-CT and SF-36v2 Acute questionnaires. These tools ask about quality of life and physical functioning.

    The study records any treatment-emergent adverse events, which means new health problems that appear after treatment starts, and any serious adverse events, which means serious health problems. It also records any side effects that lead to stopping treatment permanently.

  3. Step 3

    <b>extension phase</b>

    If you enter the extension phase, you continue with study assessments that include body weight, body mass index (BMI), which is a measure based on height and weight, waist size, blood pressure, blood sugar measures, lipids, hsCRP, and the same types of questionnaires about daily life and physical function.

    The study also continues to track treatment-emergent adverse events, serious adverse events, and side effects that lead to permanent stopping of treatment.

    The extension phase also measures relative change in body weight and change in body weight over time.

  4. Step 4

    <b>study end</b>

    Your participation ends after the study treatment and any extension phase assessments are completed.

    The full study is planned to run from 2026-04-06 to 2029-07-31.

Who can join the trial?

3 criteria

  • Male or female at birth.
  • At least 18 years old when signing the informed consent form, which is the written permission to join the study.
  • Body mass index (BMI) of 30 kg/m² or higher, or another study-specified BMI level if applicable. BMI is a measure that uses height and weight to estimate body size.

Who cannot join the trial?

3 criteria

  • HbA1c of 6.5% or higher at screening. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
  • A history of type 1 diabetes or type 2 diabetes, whether the patient reports it or it is written in the medical records.
  • Use of any of these medicines before screening: GLP-1 receptor agonists (medicines that help lower blood sugar and may reduce appetite), dual GLP-1/GIP receptor agonists (medicines that act on two hormone targets), any other GLP-1-based treatment, or amylin analogues (medicines similar to a hormone that helps control blood sugar and appetite).
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Investigated drugs

Zenagamtide is the study medicine being tested in this trial. It is given as a shot under the skin using a pre-filled pen. The trial is checking whether it can help people with obesity lose weight when taken once a week, and whether it is safe to use.

What is already known about the treatment

  • Placebo

    Placebo is an inactive treatment given by subcutaneous injection in a pre-filled pen so that the trial can compare it with the active medicine under the same conditions. It has no therapeutic ingredient and does not act on the body in the way a real drug does, so it is used only as a control in medical research. Placebo is not a medicine used to treat obesity, but it helps researchers judge whether any weight change is truly caused by the tested drug.

  • Zenagamtide

    Zenagamtide is an experimental medicine given as a subcutaneous injection, usually once weekly, using a pre-filled pen. It is still under study and is not yet an established treatment in regular medical practice, but it is being tested in medical literature for weight loss in people with obesity. It is classified as an anti-obesity medicine and is designed to reduce appetite and food intake by acting on hormone-like pathways involved in hunger control, although its exact molecular action is still being studied.

Investigated diseases

Obesity - Obesity is a long-term disease in which excess body fat builds up to a level that can affect health. It usually develops gradually when body energy intake stays higher than energy use over time. The condition often progresses with increasing body weight, a larger waist size, and a higher body mass index. As it advances, it may be associated with changes in blood sugar, blood pressure, blood fats, and overall physical comfort and function.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520440-42-00Protocol codeNN9490-8021Estimated enrolment1 120 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).