Zenagamtide Compared with Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes

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What is this study about?

This clinical trial is studying type 2 diabetes in people with overweight or obesity. It compares a new medicine called NNC0487-0111, also known as zenagamtide, with semaglutide, which is already used for weight management and diabetes care. The purpose of the study is to see whether NNC0487-0111 helps lower body weight better than semaglutide and to learn more about its safety.

Both medicines are given as a subcutaneous injection, which means an injection under the skin, once a week. People in the study receive one of several dose plans of NNC0487-0111 or semaglutide, and some study groups receive placebo. The study follows changes in body weight, blood sugar, waist size, blood pressure, and other health measures over time. It also looks at side effects, including low blood sugar, which can happen when blood sugar drops too far.

The study is planned to run for a long period, with treatment and follow-up visits spread across the study time. The medicines are given in a pre-filled pen, and the course of the study is designed to compare how the different treatments work and how safe they are in adults with excess body weight and type 2 diabetes.

Who Can Join the Study?

  • Adults who are 18 years of age or older when they sign the consent form.
  • Both men and women can take part.
  • A body mass index (BMI) at screening that is at least the required study value. BMI is a measure of body weight compared with height.
  • Have type 2 diabetes that was diagnosed at least 180 days before screening.
  • Have a hemoglobin A1c (HbA1c) result between 7% and 10% at screening. HbA1c is a blood test that shows average blood sugar over the past 2 to 3 months.
  • Have been treated with lifestyle changes and/or up to 3 oral diabetes medicines before screening. Lifestyle changes means changes in eating, physical activity, and weight management.
  • If using oral diabetes medicines, the treatment must have been stable before screening. Stable means the same medicine or medicines, the same dose, and the same number of times taken each day for the required time before screening.
  • The oral diabetes medicines allowed include metformin, alpha-glucosidase inhibitors (medicines that help slow sugar absorption from food), glinides, SGLT2 inhibitors (sodium-glucose cotransporter 2 inhibitors, medicines that help the kidneys remove sugar in urine), thiazolidinediones, and sulfonylureas.

Who Cannot Join the Study?

  • Kidney function too low: if the estimated glomerular filtration rate, or eGFR (a test that shows how well the kidneys filter blood), is below 30 mL/min/1.73 m² at screening.
  • Eye disease with recent or expected treatment: if the participant has diabetic retinopathy or maculopathy (eye damage caused by diabetes that can affect vision) and has had treatment with retinal photocoagulation (laser treatment for the retina), vitrectomy (surgery to remove gel from the eye), or anti-VEGF treatment (medicine that blocks abnormal blood vessel growth) within 180 days before screening, or is expected to need such treatment within 180 days after screening.
  • Eye condition not properly checked: if diabetic retinopathy or maculopathy has not been confirmed with an eye examination done within 90 days before screening or between screening and randomization.
  • Pupil dilation needed for the eye exam: the eye examination must usually include pupil dilation (drops that widen the pupil) unless a special digital camera is used that does not require dilation.
  • Not able to sense low blood sugar: if the participant has hypoglycaemic unawareness, meaning they do not notice the warning signs of low blood sugar, as judged by the investigator using a questionnaire.
  • Repeated severe low blood sugar: if the participant has had recurrent severe hypoglycaemic episodes (more than one serious low blood sugar event) during the last year, as judged by the investigator.
  • Recent use of certain diabetes medicines: if the participant has used GLP-1 receptor agonists, dual GLP-1/GIP receptor agonists, any other GLP-1-based treatment, or amylin analogues within the required washout period before screening. A washout period is the time that must pass after stopping a medicine so it no longer affects the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
University Of Debrecen Debrecen Hungary
Multiprofile Hospital For Active Treatment Knyaginya Klementina Sofia EAD Sofia Bulgaria
General Hospital Dr. Josip Bencevic Slavonski Brod Croatia
Opca Bolnica Karlovac Karlovac Croatia
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Multispecialty hospital for active treatment Sveta Sofia EOOD Sofia Bulgaria
Zentrum fuer klinische Studien Suedbrandenburg GmbH Elsterwerda Germany
KliFoCenter GmbH Witten Germany
Spital Judetean De Urgenta Satu Mare Satu Mare Romania
Poliklinika Solmed d.o.o. Zagreb Croatia
Medical Center Zdrave-1 OOD Kozloduy Bulgaria
Herz Und Diabeteszentrum NRW Bad Oeynhausen Universitaetsklinik Der Ruhr-Universitaet Bochum Bad Oeynhausen Germany
APDP Associacao Protectora Dos Diabeticos De Portugal Lisbon Portugal
Medical Institute Ministry Of Interior Sofia Bulgaria
Lukmed 2 Sp. z o.o. Siedlce Poland
Nutrilife S.R.L. Bucharest Romania
Borbanya Praxis Egeszsegugyi Kft. Nyiregyhaza Hungary
Komaromi Selye Janos Korhaz Komarom Hungary
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Cabinet Medical Dr Geru S.R.L. Timisoara Romania
Beata Miklaszewicz & Dariusz Dabrowski Cardiamed Sp. j. Legnica Poland
Smo Md GmbH Magdeburg Germany
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Medcenter Nova Clinic Ltd. Varna Bulgaria
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice Krapinske Toplice Croatia
Sc Cmi Dr. Pletea Noemi S.R.L. Bacau Romania
Opca Bolnica Varazdin Varazdin Croatia
Hospital Das Forcas Armadas Lisbon Portugal
Poliklinika MEDIKOL Zagreb Croatia
Gabinety Medyczne MATUSZEK Beata Matyjaszek-Matuszek Prywatna Praktyka Specjalistyczna Lublin Poland
Savokaexhlgmdki Gitjhwc Dhsjoytfxikmqdp Rvdwiton Rdvutladsqg Gorzów Wielkopolski Poland
Cnikrrr fpl Dmnbpeuvkixd ukh Azwidhaaocpdtfcg Pohlheim Germany
Insfzzcx ftt Dyykmeektunbdvnxi Orhnhrrdd Osnabrück Germany
Dyvlwyxlywrleziwkwzifsw Cpyucs I Pvyiyn Emba Pleven Bulgaria
Ewmtee Saj z ozjb Lublin Poland
Nwjt Vmrq Dwdtzdphl Medxydpavq Bjorvtlo Bialystok Poland
Sswbz Slg z oixe Leszno Poland
Mgbpity Pklxqtyi Sgmlvz Oradea Romania
Miczvrh Cpltff Aaomv Ijt Pldihqk Eugh Sofia Bulgaria
Klpgezcl bqguivot cszijy Rzvhzk (kjaypdvr Hddksfys Ceziyd Retpftd Rijeka Croatia
Pcbd Ctnczkex Mhj Suakck Reghin Romania
Gskh Sqbup Pkhgztxub Cjcqkzo Sito Cascais Portugal
Sgkqdjwlell Peunawcjj Sxligti Kjccqinpm Nt 1 Ivhfhzxtdjvfhuxnie Swymxvk Sitdsbpau Ukoixozaiepk Mmcxfnbeso W Kwqgtptely Zabrze Poland
Dfaozj Mke Slvwvp Bucharest Romania
Pfpvzivwgih Gqejercvo Sgo z omot Grudziadz Poland

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

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Recruiting
20.05.2026
Croatia Croatia
Recruiting
20.05.2026
Germany Germany
Recruiting
20.05.2026
Hungary Hungary
Recruiting
20.05.2026
Poland Poland
Recruiting
20.05.2026
Portugal Portugal
Recruiting
20.05.2026
Romania Romania
Recruiting
20.05.2026

Trial locations

Investigated drugs:

zenagamtide is the study medicine being tested in this trial. It is given as a shot under the skin once a week using a pre-filled pen. The trial is checking how well it helps with weight loss and whether it is safe for people with overweight or obesity and type 2 diabetes.

semaglutide is the comparison medicine in this trial. It is also given as a shot under the skin once a week using a pre-filled pen. The study uses it to see how the new study medicine works compared with a medicine already used for weight management and diabetes-related care.

Obesity – A long-term condition in which excess body fat builds up to a level that can affect health. It usually develops gradually when energy intake regularly exceeds energy use, leading to increasing body weight over time. The condition can remain stable, or body weight may continue to rise if the imbalance persists.

Trial ID:
2024-520446-31-00
Protocol code:
NN9490-8028
Trial Phase:
Therapeutic confirmatory (Phase III)

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