A Study of Zenagamtide in Adults With Overweight or Obesity and Type 2 Diabetes

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What is this study about?

This clinical trial is studying overweight or obesity and type 2 diabetes. The medicine being tested is NNC0487-0111, also called zenagamtide, given as a subcutaneous injection, which means an injection under the skin. The study is being done to see how well different doses of this medicine work and to check its safety compared with placebo.

People in the study receive one of several weekly dose levels of NNC0487-0111 or placebo. The treatment is given with a pre-filled pen and the study lasts for many months. During the study, body weight, blood sugar control, and other health changes are followed, along with any unwanted effects.

The study is designed to find out whether NNC0487-0111 can help reduce body weight in people who have excess body weight and type 2 diabetes. It also looks at changes in waist size, blood sugar, blood pressure, blood fats, and quality of life, as well as safety issues such as low blood sugar and other side effects.

Who Can Join the Study?

Be an adult, meaning 18 years of age or older when signing the consent form.
Be male or female at birth.
Have a body mass index (BMI) that meets the study requirement. BMI is a number based on height and weight used to describe body size.
Have overweight or obesity and type 2 diabetes.
Have been diagnosed with type 2 diabetes mellitus at least 180 days before the screening visit. Screening is the set of tests and checks done before joining the study.
Be treated with lifestyle intervention, which means changes such as diet and exercise, and/or take 0 to 3 oral antidiabetic medicines approved in the local country.
If taking oral antidiabetic medicines, use only the allowed medicines, such as metformin, alpha-glucosidase inhibitors (medicines that slow sugar absorption from food), glinides, SGLT2 inhibitors (medicines that help remove sugar through the urine), thiazolidinediones, or sulfonylureas, either alone or in combination as allowed by the study.
Have been on the same oral antidiabetic medicine or medicines, with the same drug, same dose, and same dosing schedule, for at least the required stable period before screening.
Have an HbA1c level between 7% and 10% at screening. HbA1c is a blood test that shows the average blood sugar level over the past 2 to 3 months.

Who Cannot Join the Study?

Kidney function is too low, with an estimated glomerular filtration rate, or eGFR, below 30 mL/min/1.73 m² at screening. eGFR is a blood test estimate of how well the kidneys are filtering waste.
Has diabetic retinopathy or maculopathy that was treated with laser eye treatment (photocoagulation), vitrectomy (eye surgery to remove gel from inside the eye), or anti-VEGF medicine within the last 180 days before screening, or is expected to need such treatment within 180 days after screening.
The eye condition must have been checked by an eye examination within 90 days before screening, or between screening and randomisation. A dilated eye exam is required unless a special digital eye camera was used that does not need pupil dilation. Pupil dilation means using drops to widen the pupil.
Has known hypoglycaemic unawareness, meaning the person does not notice low blood sugar symptoms, as judged by the study doctor using a standard question.
Has had repeated severe low blood sugar episodes in the last year, as judged by the study doctor. Severe low blood sugar means an episode that is dangerous or needs help from another person.
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 is no longer affecting the body.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Oliver-Med s.r.o.	Rimavska Sobota	Slovakia
Poliklinika SLAVONIJA OSIJEK za opcu kirurgiju radiologiju baromedicinu ginekologiju i porodiljstvo i internu medicinu	Osijek	Croatia

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Nutrilife S.R.L.	Bucharest	Romania
DRC Kft.	Balatonfured	Hungary
Specijalna Bolnica Za Medicinsku Rehabilitaciju Krapinske Toplice	Krapinske Toplice	Croatia
Opca Bolnica Varazdin	Varazdin	Croatia
Narodny Endokrinologicky A Diabetologicky Ustav	Lubochna	Slovakia
Sc Cmi Dr. Pletea Noemi S.R.L.	Bacau	Romania
Areteus s.r.o.	Trebisov	Slovakia
Opca Bolnica Karlovac	Karlovac	Croatia
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Spital Judetean De Urgenta Satu Mare	Satu Mare	Romania
Poliklinika Solmed d.o.o.	Zagreb	Croatia
Somogy Varmegyei Kaposi Mor Oktato Korhaz	Kaposvar	Hungary
Thalassotherapia Specijalna bolnica za medicinsku rehabilitaciju bolesti srca pluca i reumatizma	Opatija	Croatia
University Of Szeged	Szeged	Hungary
DEImedi s.r.o.	Šurany	Slovakia
Trantor 99 Bt.	Budapest	Hungary
Pula General Hospital Ospedale Generale di Pola	Pula	Croatia
PVN Kutato Kft.	Budapest	Hungary
Dia Kontrol s.r.o.	Levice	Slovakia
Poliklinika za oftalmologiju optometriju i neurologiju Lux	Solin	Croatia
A & C Medical Prime S.R.L.	Craiova	Romania
CMI DR. COJOCARU CRISTINA	Constanta	Romania
Pakhm Fdidap Mn sfacyk	Sahy	Slovakia
Txn Dthreg Sszczr	Craiova	Romania
Dwnofe Mrg Syngze	Bucharest	Romania
Ccqgrlk Dxxezffswkas Strdyi	Bucharest	Romania
Akpzfzj Uihbr Sjpekgpps Lodcas Dz Bdicwto	Bologna	Italy
Ugwrupwixu Dcjpq Skxxy Du Rdne Lu Snahnfjv	Rome	Italy
Srwjd Mfviqu Rdqhlriqeofejm Nsbsecnjd Kwmn	Budapest	Hungary
Pmqu Cecxtzlf Mnm Scfbam	Reghin	Romania

Trial status

Country	Status	Recruitment Start
Croatia	Recruiting	30.04.2026
Hungary	Not yet recruiting	30.04.2026
Italy	Recruiting	30.04.2026
Romania	Recruiting	30.04.2026
Slovakia	Recruiting	30.04.2026

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 looking at whether it helps people with overweight or obesity and type 2 diabetes lose body weight better than placebo, while also checking how safe it is.

Investigated diseases:

Overweight – Overweight is a condition in which body weight is higher than what is considered healthy for a person’s height. It usually develops gradually when energy intake regularly exceeds energy use, leading to excess body fat. Over time, it can increase waist size and may be accompanied by changes in blood sugar, blood pressure, and blood fats.
Obesity – Obesity is a condition marked by an unhealthy amount of body fat. It often develops slowly over time and can worsen as excess weight continues to build, especially when energy intake stays higher than energy use. It may be associated with increasing body mass index and waist circumference, along with changes in blood sugar, blood pressure, and blood fats.
Type 2 Diabetes Mellitus – Type 2 diabetes mellitus is a long-term condition in which the body does not use insulin properly, causing blood sugar to rise. It usually develops gradually and may begin with mild changes in blood sugar before becoming more persistent. Over time, blood sugar control can worsen, and the condition may be linked with changes in weight, waist size, and blood pressure.

Trial ID:

2024-520441-23-00

Protocol code:

NN9490-8024

Trial Phase:

Therapeutic confirmatory (Phase III)

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A Study of Zenagamtide in Adults With Overweight or Obesity and Type 2 Diabetes

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?