Zenagamtide for Weight Loss in Adults with Obesity

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What is this study about?

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.

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 <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 <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 <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 Study?

  • 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 Study?

  • 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).

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
MVZ im Altstadt-Carree Fulda GmbH Fulda Germany
Katholieke Universiteit te Leuven Leuven Belgium
Oncopole Claudius Regaud Toulouse France
Université Libre de Bruxelles – Hôpital Erasme Brussels Belgium

Other Sites

Site Name City Country Status
Sanos A/S Gandrup Denmark
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
Universitair Ziekenhuis Gent Gent Belgium
Algemeen Ziekenhuis Delta Roeselare Belgium
Centre De Recherche Clinique Portes Du Sud Venissieux France
Smo Md GmbH Magdeburg Germany
Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda Germany
KliFoCenter GmbH Witten Germany
Gentofte Hospital Hellerup Denmark
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Madasmxz Mechelen Belgium
Idqmwmii fqb Dkaizpmunwpbpcxec Oidgptogw Osnabrück Germany
Ugllgaccts Og Acszwfh Edegem Belgium
Hezsiu Havztume Herlev Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Recruiting
06.04.2026
Denmark Denmark
Recruiting
06.04.2026
France France
Recruiting
06.04.2026
Germany Germany
Recruiting
06.04.2026

Trial locations

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.

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 ID:
2024-520440-42-00
Protocol code:
NN9490-8021
Trial Phase:
Therapeutic confirmatory (Phase III)

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