Weight loss in adults with obesity (with or without type 2 diabetes) using cagrilintide and semaglutide: a study of two dose levels versus semaglutide alone

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What is this study about?

The study focuses on adults who have obesity and may also have type 2 diabetes. Two treatments are being compared: a single medication called semaglutide given by injection once a week, and a new combination product that contains both cagrilintide and semaglutide, referred to as CagriSema, also given by injection once weekly at two different dose levels.

The aim is to determine whether the combination product leads to greater loss of body weight than semaglutide alone when participants also follow a reduced‑calorie diet and increase their physical activity. Participants will receive the assigned injection for several months, attend regular clinic visits to check weight, waist size, BMI, blood sugar levels, and any side effects, and will be asked to record their diet and exercise habits throughout the study.

1 baseline assessment

after joining the study you will attend an initial visit where your weight, height, waist size, blood pressure, and blood samples are measured. these measurements establish a starting point for later comparisons.

the study staff will also review your medical history, current medicines, and any allergies to ensure the trial drugs are safe for you.

2 receive study medication

you will be given a pre‑filled injection device containing either cagrilintide semaglutide (the test medication) or semaglutide (the comparator medication). the exact dose is assigned by the study and is described as 0 mg in the study documentation.

the medication is delivered by subcutaneous injection, which means it is placed under the skin using a small needle.

3 start weekly injections

you will inject the medication once each week, on the same day of the week, as instructed. the injection is given under the skin of the abdomen or thigh.

continue the weekly injections for the entire treatment period defined by the study protocol.

4 follow diet and activity plan

the study includes a reduced‑calorie diet plan that aims to lower your daily energy intake. you will receive written guidance on portion sizes and food choices.

you are also asked to increase physical activity, such as walking, cycling, or other moderate exercises, according to the schedule provided by the study team.

5 regular follow‑up visits

you will return to the clinic at scheduled intervals (typically every 4 to 8 weeks) for safety checks and progress monitoring.

during each visit the staff will record your weight measurement, waist circumference, and may draw blood for tests such as cholesterol, glucose, and other safety labs.

6 report side effects

if you experience any discomfort, unusual symptoms, or health changes, you should inform the study staff promptly. these are called adverse events and are recorded to evaluate the safety of the medication.

7 final assessment

at the end of the treatment period you will attend a final visit where all measurements taken at baseline are repeated.

the final data will be used to determine changes in body weight, body‑mass index, and other health indicators compared with the start of the study.

Who Can Join the Study?

  • Anyone who was assigned male or female at birth, including all gender identities, can join.
  • You must be at least 18 years old when you sign the informed consent form.
  • Your Body Mass Index (BMI) must be 35 or higher. BMI is a number that compares your weight to your height to see if you are considered overweight.
  • If you do not have type 2 diabetes (T2D), you must have never been diagnosed with it and your glycated haemoglobin (HbA1c) level must be less than 6.5% (48 mmol/mol). HbA1c is a blood test that shows your average blood‑sugar level over the past three months.
  • If you have type 2 diabetes (T2D), you must have a known history of the condition and your glycated haemoglobin (HbA1c) level must be less than 10% (86 mmol/mol).
  • If you are screened and your HbA1c is 6.5% (48 mmol/mol) or higher, a doctor must confirm that you have type 2 diabetes before you can be randomly placed into a treatment group.

Who Cannot Join the Study?

  • A self‑reported change in your body weight of more than 5 % within the 90 days before screening prevents participation.
  • Use of any medication that is a glucagon‑like peptide‑1 receptor agonist (GLP‑1 RA)—drugs that help lower blood sugar and often aid weight loss—or any amylin analogue, which mimics a natural hormone that controls appetite, within the past 6 months prevents participation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Endomed s.r.o. Kosice Slovakia
Brain Research Center Den Bosch B.V. S-Hertogenbosch The Netherlands
Milan Kvapil s.r.o. Prague Czechia
Uniwersytecki Szpital Kliniczny W Bialymstoku Bialystok Poland
Hospital Vall d’Hebron Barcelona Spain
Ludia s.r.o. Spisska Nova Ves Slovakia
Obudai Egeszseguegyi Centrum Kft. Dunaújváros Hungary
Hospital Universitario da A Coruna A Coruna Galicia Spain
Ospedale San Raffaele S.r.l. Milan Italy
Medical University Of Vienna Vienna Austria
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Semmelweis University Budapest Hungary
IRCCS Ospedale Policlinico San Martino Genoa Italy
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Klinik Hietzing Vienna Austria
Medical University Of Graz Graz Austria
University Of Szeged Szeged Hungary
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Rijnstate Ziekenhuis Stichting Arnhem The Netherlands
Hospital Universitario De La Princesa Madrid Spain
Hospital Santa Maria Della Misericordia Perugia Italy
Klinik Landstrasse Vienna Austria
Universita Degli Studi Di Brescia Brescia Italy
University Magna Graecia Of Catanzaro Catanzaro Italy
Eap Osona Sud Alt Congost S.L.P. Centelles Spain
Vita Longa Sp. z o.o. Katowice Poland
Spaarne Gasthuis Hoofddorp The Netherlands
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Hospital Universitario Virgen De La Victoria Malaga Spain
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Evangelismos S.A. Athens Greece
Laiko General Hospital Of Athens Athens Greece
Alexandra Hospital Athens Greece
Athens Medical Center S.A. Thessaloniki Greece
Algemeen Ziekenhuis Delta Roeselare Belgium
University Multiprofile Hospital For Active Treatment Saint Georgi EAD Plovdiv Bulgaria
Centre Hospitalier De Colmar Colmar France
Centre Hospitalier Universitaire Rouen Rouen France
Spitalul Clinic Judetean De Urgenta Pius Brinzeu Timisoara Romania
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Medical Centre Nevromedics EOOD Veliko Tirnovo Bulgaria

Other Sites

Site Name City Country Status
KARDIOLOGIE LIBEREC s.r.o. Liberec Czechia
Gaja Poradnie Lekarskie Poznan Poland
Hospital Da Luz S.A. Lisbon Portugal
Gyncentrum Sp. z o.o. Katowice Poland
Trial Pharma Kft. Gyula Hungary
Consorci D’atencio Primaria De Salut Barcelona Esquerra Barcelona Spain
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
Hospital de Antequera Antequera Spain
CardioMetabolicCenter-CMC Ordination Winhofer-Stöckl Mattersburg Austria
Centrum zdravi Dolni Brezany a.s. Dolni Brezany Czechia
General Hospital Of Thessloniki G Gennimatas Thessaloniki Greece
Kormont Kluisbergen Belgium
NextHealth S.A. Thessaloniki Greece
Sal Med S.R.L. Pitesti Romania
Outpatient Clinic For Specialized Outpatient Medical Care In Endocrinology Dr Albena Dinkova EOOD Pleven Bulgaria
Diagnostic Consultation Center XX-Sofia EOOD Sofia Bulgaria
Medical Center Kazanlak EOOD Kazanlak Bulgaria
Ekk Kbisqat Pjufj aqxg Prague Czechia
Hkrwwhayol sqdvxs Kosice Slovakia
Gmtkgxx Lfwztzci Oopcqulx i Cktoni Dmsmeilijoyjqu Bialystok Poland
Djkbibgkov sdryjq Bojnice Slovakia
Kmpotvy Sxx z ox oh Ostrow Mazowiecka Poland
Iyzqshu a dqzlivbrmwnike onrgmklq sdcggy Nachod Czechia
Cmtlvik Kpneaukuqqjcsvofwu Glayiingifj Misjyb Gpwjyba Bydgoszcz Poland
Eqqlsgmdtqamc Bwm Baja Hungary
Mcbvw Ceqzwogn Rbvjkaos Sfl z ozum Warsaw Poland
Bkowptt Ktkz Biatorbagy Hungary
Dxkqkma svjeji Plzen Czechia
Cvbtigtzykblh Kgic Budapest Hungary
Ees Lxdxzn Lublin Poland
Hybnbgsi Rjbks Jbho Bcrta Madrid Spain
Lojbljj Kuwz Baja Hungary
Mwyvzugjswxs Krco Nyiregyhaza Hungary
Iaknu Ibnjb Imugxeea Nsxloytdz Di Rjpgbndu E Ckaw Phe Aaorwgt Ancona Italy
Jtjqxvwfaesxajwjvfyl Vixlnucmt Hdsnqwt Gseu Kxkvmgllqqezyihnnqmft Szolnok Hungary
Pct Fvuiecx Assmcv Srj z oqni Katowice Poland
Majknoknwmv Coxihlr Kjeyjzfio Cracow Poland
Cmdfszs Mpkjofmi Ozcfsb Wroclaw Poland
Ucyrvvw Ldhbn Do Srjzf Dt Menfmudgva Ewtjoz Senhora Da Hora Portugal
Ihxgzt Zskgcwrcoo Rotterdam The Netherlands
Pfivwecxbr Kteh Bekescsaba Hungary
Piftlfx Tqdvr &dtpi Rpsdieqgqgr Bvey Beek Lb The Netherlands
Agoatwf Xipln Aiasuiwizsrd Ufsgcxldhbayk Dx Mdjpgkw Fbyoyfag Pfvglkt Manresa Spain
Kdhjacctqjkh sakty s rqoc Devinska Nova Ves Slovakia
Muwvajaxvhiu sqyapo Petrzalka Slovakia
Rqqhe Cayncs Sal z onhe Bialystok Poland
Dktovku sleowh Bytca Slovakia
Cjyrcqj Buirir Sthu Girona Spain
Ogltkltkmr Dwi Emravs Fvozhcrbkheyjxa St. Stefan ob Stainz Austria
Bggvsqsz Dlwoevyf Rhiuawyu Cfluhr Bzem Hoogeveen The Netherlands
Faokyc spnujh Prague Czechia
Dikvgmgtg syrfhe Martin Slovakia
Hzreahdasbtnziawxb Mrtxpp Bhhx Hague The Netherlands
Ocqxtedaxn Dme Ipdhre Vienna Austria
Onxoftuwpj Dgh Gizctz Svqsh Vienna Austria
Hlfojddy Uenpmrifcvbll Spycfqy Vtbvjy dde Mfu Madrid Spain
Ebvjlueac sbfra Prague Czechia
Mvcrljmc Mechelen Belgium
Cfdvgm heyxdkfbfji ubwvekpspxdvb dl Tlpxua Irfnwiul mvweybu dpf Mkwkrlsdyy sqphsptklbn La Louviere Belgium
Aflmp Alken Belgium
Tncmut Cuzgdn Sddb Thessaloniki Greece
Gmcjbwq Hqcwkikq Ok Lamwv Lamia Greece
Ssycrdzh Cljmza Jbkuwbsk Db Ujgfgib Bfwoz Oradea Romania
Myb Chid Bqjanefdn Sxbdcu Buzau Romania
Tof Dnpicd Sfiaqn Craiova Romania
Mrbnmau Ccnbye Mugf Coon Onr Kyustendil Bulgaria
Nfjbosfu Shcvgc Bucharest Romania
Cuomjd Do Rhjqhywrm Cojpxwct Pqyliw Dw Set Venissieux France
Cdqktjy Mqljctd Dw Gyga Szfkok Timisoara Romania
Mpelol Snrqvn Targu Mures Romania
Gejmuhct Smedad Oradea Romania
Lnf Hdmlloyz Dc Crdvsfxd Le Coudray France
Moglmny coxllq 4trgv Lete Burgas Bulgaria
Dsqewixhms Mscieag Cantyr 2hwz Ldcy Dimitrovgrad Bulgaria
Czvmxbi Mlbduja Izcusnzzyl Dyfpqgh Ngsnbufzq Bjyz Mebivjsghj Djn Phx Lomjllg Baia Mare Romania
Mxtbvch Acnf Mehbvtz Duntat Chbuns Emqx Sofia Bulgaria
Oybgqqitkb Ciyrdd Fws Ijhkuthogm Pftswqpx Avf Szujqkvpfvm Mtydazx Chrv Dux Ekxpsxf Zcrhjtkoh Enjz Varna Bulgaria
Muattmkly Cljxbl Sstvbn Brasov Romania

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

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
14.05.2026
Belgium Belgium
Not recruiting
14.05.2026
Bulgaria Bulgaria
Not recruiting
14.05.2026
Czechia Czechia
Not recruiting
14.05.2026
France France
Not recruiting
14.05.2026
Greece Greece
Not recruiting
14.05.2026
Hungary Hungary
Not recruiting
14.05.2026
Italy Italy
Not recruiting
14.05.2026
Poland Poland
Not recruiting
14.05.2026
Portugal Portugal
Not recruiting
14.05.2026
Romania Romania
Not recruiting
14.05.2026
Slovakia Slovakia
Not recruiting
14.05.2026
Spain Spain
Not recruiting
14.05.2026
The Netherlands The Netherlands
Not recruiting
14.05.2026

Trial locations

Investigated Drugs:

Semaglutide is a medication that is given as an injection under the skin. In this study it is used as the standard treatment (comparator) that participants receive once a week. The drug helps lower blood sugar and can also lead to weight loss, so it is being tested to see how well it works when added to a reduced‑calorie diet and more physical activity.

Cagrilintide semaglutide is a new combination therapy that contains both cagrilintide and semaglutide in a single injection given under the skin. In the trial this combination is the experimental treatment (test) and is being compared to semaglutide alone to see if adding cagrilintide improves weight loss and safety for people with obesity, with or without type 2 diabetes.

Investigated Diseases:

Obesity – A condition characterized by an excess amount of body fat that builds up over time, often because more calories are taken in than are used. The increase in fat can be gradual and may become noticeable as weight and waist size grow. As the condition progresses, it can make everyday activities feel more difficult and may affect a person’s comfort and mobility.

Type 2 diabetes mellitus – A metabolic disorder where the body does not respond properly to insulin, leading to higher levels of sugar in the blood. It usually develops slowly and is often associated with excess weight. Over time, the body may have trouble regulating blood sugar, causing frequent thirst, increased urination, and a feeling of low energy.

Trial ID:
2025-522488-14-00
Protocol code:
NN9838-7910
Trial Phase:
Therapeutic confirmatory (Phase III)

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