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A study on the effectiveness of cagrilintide and semaglutide for weight management in children and adolescents with obesity

3 1

What is this study about?

This study focuses on Obesity and Type 2 Diabetes, which is a condition where the body cannot properly use blood sugar. The research aims to evaluate the effectiveness and safety of different treatment options for weight management. The medications being studied include cagrilintide, semaglutide, and a combination of both known as CagriSema. These treatments are administered via subcutaneous injection, which means the medicine is injected into the fatty layer just under the skin.

Participants in the study may receive cagrilintide alone, the combination of cagrilintide and semaglutide, semaglutide alone, or a placebo. The study involves monitoring changes in Body Mass Index, which is a measurement used to determine if a person has a healthy weight for their height, and the BMI Standard Deviation Score, a calculation that compares a person’s body mass to the average for others of the same age and sex. The course of the study involves weekly injections over a period of time to observe how these substances affect body weight and overall health.

1 treatment phase

during the 68-week treatment period, a weekly subcutaneous injection (an injection given under the skin) is administered.

the subcutaneous injection will consist of one of the following options: cagrilintide, semaglutide, cagrilintide and semaglutide (known as CagriSema), or a placebo (an inactive substance that does not contain medication).

2 monitoring and evaluation

the progress of body mass index (a measure of body fat based on height and weight) and body weight is monitored from the start of the treatment through week 68.

changes in the bmi standard deviation score (a way to compare weight to other individuals of similar age and sex) are also recorded during this period.

Who Can Join the Study?

  • The parents or a legal guardian must sign a document called informed consent, which means they give permission for the child to join the study after understanding all the details.
  • The child must also provide assent, which is a way of showing they agree to participate in the study in a way that is appropriate for their age.
  • The participant can be any gender (male or female).
  • The child must be between 8 and 17 years old at the time the permission forms are signed.
  • Children aged 8 to 11 must have a Body Mass Index (BMI)—a measure of body fat based on height and weight—that is at or above the 95th percentile, meaning their weight is higher than 95% of other children their age.
  • Adolescents aged 12 to 17 must have a BMI at or above the 95th percentile, or at or above the 85th percentile if they also have an obesity-related complication, such as type 2 diabetes (a condition where the body cannot properly control blood sugar), hypertension (high blood pressure), dyslipidaemia (unhealthy levels of fats/cholesterol in the blood), or obstructive sleep apnoea (a condition where breathing repeatedly stops and starts during sleep).
  • Blood tests must show that levels of calcium, phosphate, alkaline phosphatase, and parathyroid hormone (minerals and hormones that help manage bone and blood levels) are within the normal range for the child’s age and sex.
  • The participant must have tried to lose weight through a structured lifestyle modification programme (a planned program of healthy eating and physical activity) for at least 3 months without success.
  • The child’s weight must be greater than 45 kg at the start of the study.
  • The HbA1c level, which is a blood test that shows the average blood sugar levels over the past few months, must be 10.0% or lower.
  • The child must be currently using a lifestyle intervention (healthy eating and exercise plans) or taking a medication called metformin.
  • If taking metformin, the dose and how often it is taken must have remained the same for at least 56 days before the study begins.

Who Cannot Join the Study?

  • Taking any medicine for obesity (being significantly overweight) or weight management within 90 days before starting the study.
  • Having frequent and severe hypoglycaemic episodes, which means sudden and dangerous drops in blood sugar levels, within 1 year before starting the study.
  • Testing positive for IA-2 antibodies or anti-GAD antibodies, which are specific markers in the blood that can indicate certain types of diabetes.
  • Taking any medicine for diabetes other than the ones specifically allowed in the study within 90 days before starting.
  • Having uncontrolled diabetic retinopathy or maculopathy, which are eye problems caused by diabetes that affect vision and are not currently stable or well-managed.
  • Having had, or planning to have, obesity surgery or using a weight loss device during the study, though certain procedures like liposuction or gastric bands are allowed if they were completed more than 1 year ago.
  • Having uncontrolled thyroid disease, which is a condition where the thyroid gland does not produce the right amount of hormones to regulate the body.
  • Having obesity caused by endocrine, hypothalamic, or syndromic issues, which means weight gain related to hormone imbalances or specific genetic conditions.
  • Having lost or gained more than 5% of your total body weight within the 90 days before starting the study.
  • Having Type 1 diabetes or monogenic diabetes, which are specific types of diabetes caused by different biological mechanisms than common Type 2 diabetes.
  • Having an HbA1c level of 6.5% or higher, which is a blood test that shows your average blood sugar levels over the past few months.
  • Taking any glucose-lowering agents, which are medicines used to reduce high blood sugar, for diabetes or pre-diabetes within 90 days before starting.
  • Having hypoglycaemic unawareness, which means you are unable to feel or notice the warning signs when your blood sugar levels drop too low.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Medizinische Universitaet Innsbruck Innsbruck Austria
Klinički bolnički centar Zagreb (University Hospital Center Zagreb) Zagreb Croatia
Children’s Health Medical Center EOOD Sofia Bulgaria
Kliniczny Szpital Wojewodzki Nr 2 Im. Sw. Jadwigi Krolowej W Rzeszowie Rzeszow Poland

Other Sites

Site Name City Country Status
Uniwersytecki Szpital Kliniczny W Opolu Opole Poland
Narodny Endokrinologicky A Diabetologicky Ustav Lubochna Slovakia
Semmelweis University Budapest Hungary
Hrohhvdr Vdcm dorsarie Barcelona Spain
Vxbslw dyp Rlemi Uzmqiojfxm Hioodtzt Sevilla Spain
Fiptydjxrh Iwjkn Co Grkcmo Oqqhhyst Mqlupihz Pfzsssqcupd Milan Italy
Urrdsgrkspfvaiosb Dfgtg Slugf Dm Vjjzeb Verona Italy
Agerotn Oowzhpovvyxtjlwljlnkhapjm Mibhgrif Dfqpy Cyaqxv Novara Italy
Ubcavujilq Ol Sqnamp Szeged Hungary
Uigsadxrzs Oq Atfoack Edegem Belgium
Hesigcyi Swfq Jjwd Dv Drs Bstnhaevk Esplugues De Llobregat Spain
Vmtfs Uujgxkzaibhz Brtwmdv Jette Belgium
Syintumhaey Poyqdowwm Skfvdlk Kbjmcrvuc Ns 1 Ihkumyilcszrxfziyx Safrild Sjxiptloe Umrhrgkdfzlk Mtifnsjeco W Ktxhmgpkmk Zabrze Poland
Hfrylxlh Cvl Poyhx Ssnf Porto Portugal
Ufcajkgginf Scbwqabs Salzburg Austria
Unskkzlime Mfqeetmdmnol Hxhvgmnk Ftq Ayfsjx Tuaqpybit Sdlys Grhkzs Ems Plovdiv Bulgaria
Eqzjlkhypza Sblht Jovcy Cdqeqtwckwsdz Budapest Hungary
Sakuienlply Zdhwbe Pxxergwjbxp Zsnaxwsz Ozhtdt Zucyhjekiv Ijn Dmpaou Waqegobi W Dlpxcjwaneq Lttvxe Łomianki Poland
Swjkgvsd Cqtdcb Jkhrsniw Dq Utqfara Psts Bcarhmf Timisoara Romania
Kwyjcji Zk Dxoqgh Bbwxbnt Zvmwxv Zagreb Croatia
Sdsmdnjw Coqoie dg Uzvkpdd ptcaki Cvacz &baqsjatpeuqlviyihfphcf Bucharest Romania
Danozp Fjzemqkn Nwhbaexnh Kjjfsy Kosice Slovakia
Khwlsraw beotdmns conrwa Ruaznh (nbanntbe Higtqkif Cgsnyp Rdbsgyn Rijeka Croatia
Heobwuk Sprasyt Holbæk Denmark
Infgxpwz Dt Rzdqkrak E Cyig A Ceudnlijv Sslejqqbhsz Mpxwqik Iibvdbclg Bnbhe Gzziqgon Trieste Italy
Rjfmxj Vxpyuyhfpfuvq Umea Sweden
Jiykfi Bkvac Zdduvwgoqi Stfdmrhol S-Hertogenbosch The Netherlands
Ushuioq Luxmp Db Sqyth Db Gfvbgkcmabnm Ebuorp Vila Nova De Gaia Portugal
Mbyp Sayuf Mkxdkc Een Varna Bulgaria
Smgbvqorhll Hwrwglqr Ftt Abcbtq Tovhhqxew Oo Civxqglco Dflzpzpz Pcyhxgqws Ivar Msdqt Sofia Bulgaria
Kpnbhlse Jrqgec Saohbd Bucharest Romania
Uckxmul Ugliesjodb Hmwpkjul Uppsala Sweden
Cnuomk Hxjsaycatv Ugbaiisdgwbwq Dh Sgsbe Aobcuza Ehykmn Porto Portugal

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

Trial status

Country Status Recruitment Start
Austria Austria
Not yet recruiting
20.05.2026
Belgium Belgium
Not yet recruiting
20.05.2026
Bulgaria Bulgaria
Not yet recruiting
20.05.2026
Croatia Croatia
Not yet recruiting
20.05.2026
Denmark Denmark
Not yet recruiting
20.05.2026
Hungary Hungary
Not yet recruiting
20.05.2026
Italy Italy
Not yet recruiting
20.05.2026
Poland Poland
Not yet recruiting
20.05.2026
Portugal Portugal
Not yet recruiting
20.05.2026
Romania Romania
Not yet recruiting
20.05.2026
Slovakia Slovakia
Not yet recruiting
20.05.2026
Spain Spain
Not yet recruiting
20.05.2026
Sweden Sweden
Not yet recruiting
20.05.2026
The Netherlands The Netherlands
Not yet recruiting
20.05.2026

Trial locations

Investigated Drugs:

Cagrilintide is a medication given as a weekly injection under the skin. It is being studied to see how well it works on its own to help manage weight.

Semaglutide is a medication given as a weekly injection under the skin. In this study, it is used as a comparison to help evaluate the effectiveness of the other treatments.

Cagrilintide semaglutide is a combination treatment that includes two different medications given together in a single weekly injection under the skin. This combination is being tested to see if it is more effective for weight management than the individual medications or a placebo.

Investigated Diseases:

Obesity – This condition involves an excessive accumulation of body fat that may impair health. It often develops over time due to an imbalance between energy intake from food and energy expenditure. The condition can progress as weight increases, leading to various metabolic changes. Type 2 diabetes mellitus – This is a chronic condition that affects how the body processes blood sugar. It occurs when the body either resists the effects of insulin or does not produce enough of it to maintain normal glucose levels. Over time, blood sugar levels can rise steadily if the condition is not managed.

Trial ID:
2023-509176-42-00
Protocol code:
NN9838-4968
Trial Phase:
Human Pharmacology (Phase I) – Other

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