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A study to evaluate the efficacy and safety of zenagamtide in people with obesity

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What is this trial about?

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

This study aims to evaluate the effectiveness and safety of a new medication for people living with Obesity. The investigation focuses on whether the drug zenagamtide, also referred to by the code NNC0487-0111, helps individuals maintain weight loss over time. Participants in the study will receive either the active medication or a placebo through a subcutaneous injection, which means the medicine is delivered by a needle into the fatty layer of tissue just under the skin.

The research involves monitoring several health factors during the study period. These factors include changes in Body Mass Index, which is a way to measure body fat based on height and weight, and waist circumference. Additionally, measurements will be taken regarding systolic blood pressure and diastolic blood pressure, which represent the pressure in the arteries when the heart beats and when it rests. Other monitored aspects include blood sugar levels, such as glycated haemoglobin, and various types of lipids, which are fats found in the blood like cholesterol and triglycerides.

The research process

The trial runs in 1 step.

  1. Step 1

    Participation in the study

    Once the study begins, zenagamtide or a placebo (a substance with no active medicine) is administered.

    The zenagamtide is provided as a solution for injection in a pre-filled pen.

    This medication is given via a subcutaneous injection, which means it is injected into the fatty tissue just under the skin.

    The injection is performed once weekly.

Who can join the trial?

4 criteria

  • The study is open to both males and females (based on the sex assigned at birth).
  • Participants must be at least 18 years old at the time they sign the permission forms.
  • Participants must have a Body Mass Index (BMI) of 30 or higher. Body Mass Index is a way to measure if a person has a high amount of body fat by comparing their weight to their height.
  • Participants must have a medical diagnosis of obesity, which is a condition where excess body fat may affect health.

Who cannot join the trial?

3 criteria

  • Having a glycated haemoglobin (HbA1c) level of 6.5% or higher, which is a blood test that measures your average blood sugar levels over the past few months.
  • Having a history of type 1 or type 2 diabetes mellitus, which are conditions where the body cannot properly regulate blood sugar levels.
  • Using certain types of weight loss or blood sugar medications before the study begins, such as GLP-1 receptor agonists, dual GLP-1/GIP receptor agonists, or amylin analogues. These are medicines that mimic natural hormones in the body to help control appetite and blood sugar.
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Investigated drugs

Zenagamtide is a medication being tested to see how well it works for people living with obesity. It is administered as an injection under the skin once a week to help manage body weight.

What is already known about the treatment

Zenagamtide - This medication is an experimental treatment administered as a solution for injection through a pre-filled pen placed under the skin. It is currently being studied in clinical trials to evaluate its effectiveness and safety for managing obesity. The drug works by targeting specific receptors in the body to help regulate appetite and improve metabolic processes. It is classified as a metabolic hormone analog designed to assist in weight management.

Investigated diseases

Obesity - This is a condition characterized by an excessive accumulation of body fat. It occurs when the amount of energy consumed exceeds the energy used by the body over time. As the condition develops, it can lead to an increase in body mass index and changes in body composition. Over time, the excess fat may be stored around vital organs and throughout the body. It is often associated with changes in metabolic functions and body measurements.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-523804-62-00Protocol codeNN9490-8559Estimated enrolment600 patientsSponsorNovo Nordisk A/S

sourced from the EU Clinical Trials Register and site verification

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