DelfaGLP-1 Atlas

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RecruitingPhase 3

A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight

Efficacy, Safety and Pharmacokinetics of Cagrilintide s.c. 2.4 mg as Monotherapy and in Combination With Semaglutide s.c. 2.4 mg (CagriSema) Once Weekly for Weight Management in Chidren and Adolescents With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

119

Recruiting sites

16

Enrollment

460

estimated

Study population

Obesity / overweight

Key I/E criterion

—

Primary endpoint

•BMI, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07253285
Org study IDNN9838-4968
Secondary ID2023-509176-42European Medical Agency (EMA)
Secondary IDU1111-1299-4751World Health Organization (WHO)

Timeline

Milestones

Study first posted2025-11-28actual
Study start2026-01-08actual
Last update posted2026-04-02actual
Primary completion2030-03-20estimated
Study completion2033-09-20estimated

Assets

Investigational agents

CagriSema / cagrilintideSemaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age8 Years
Maximum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

•Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study related activities. Study related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
•The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements)
•The child must sign and date the Child Assent Form or provide oral assent (according to local requirements).
•Male or female.
•Aged 8 to less than (<) 18 years at the time of signing the informed consent.
•Body mass index (BMI), at screening, corresponding to:
•Greater than or equal to (>=) 95th percentile for children aged 8 to < 12 years (Tanner stage 1-5)
•>= 95th percentile or >= 85th percentile with the presence of at least one obesity-related complication including, but not limited to, type 2 diabetes (T2D), hypertension, dyslipidaemia or obstructive sleep apnoea for adolescents aged 12 to < 18 years (Tanner stage 2-5).
•Laboratory parameters, as measured by the central lab at screening, within normal sex- and age-specific ranges of total calcium, phosphate, alkaline phosphatase, parathyroid hormone.
•History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months.
•Body weight greater than (>) 45 kilograms (kg) at screening.

For participants with T2D at screening the following inclusion criteria also apply

•Glycated haemoglobin (HbA1c) less than or equal to (<=)10.0 percent (%) (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening.
•Treatment with lifestyle intervention or treatment with metformin according to local label.
•Treatment with metformin should be stable (same dose and dosing frequency) for at least 56 days before screening.

Key exclusion criteria:

•Treatment with any medication prescribed for obesity or weight management within 90 days before screening.
•Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed:
•Liposuction and/or abdominoplasty, if performed > 1 year before screening.
•Adjustable gastric banding, if the band has been removed > 1 year before screening.
•Intragastric balloon, if the balloon has been removed > 1 year before screening.
•Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed >1 year before screening.
•Uncontrolled thyroid disease.
•Endocrine, hypothalamic, or syndromic obesity.
•A self-reported (or by parent(s)/LAR, where applicable) change in body weight > 5 % within 90 days before screening irrespective of medical records.
•Type 1 diabetes or monogenic diabetes. For participants without T2D at screening the following exclusion criteria also apply
•HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening.
•Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening.

For participants with T2D at screening the following exclusion criteria also apply

•Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire.
•Recurrent severe hypoglycaemic episodes within 1 year before screening, as judged by the investigator.
•Positive insulinoma associated protein-2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies.
•Treatment with any medication for the indication of diabetes other than those stated in the inclusion criteria within 90 days before screening.
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Endpoints (74)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
34
Cardiometabolic biomarkers
12
Glycemic / diabetes
10
Safety / tolerability / PK
7
Patient-reported / QoL
6
MASH / liver
4
Other (unclassified)
1

Weight & body composition

34 endpoints
Primary/protocol endpoint

Relative change in body mass index (BMI)

Time frame:Baseline (week 0), week 68

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Relative change in body weight

Time frame:Baseline (week 0), week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in BMI Standard Deviation Score (SDS)

Time frame:Baseline (week 0), week 68

BMI SDS, change

change from baseline, improvement

Secondary/protocol endpoint

Relative change in BMI

Time frame:Baseline (week 0), week 68 and week 224

BMI, change

percent change from baseline, improvement

Secondary/protocol endpoint

Number of participants in weight category reduction

Time frame:Baseline (week 0), week 68

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no)

Time frame:Baseline (week 0), week 68

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved >=10% reduction of body weight (yes/no)

Time frame:Baseline (week 0), week 68

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved >=15% reduction of body weight (yes/no)

Time frame:Baseline (week 0), week 68

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved >=20% reduction of body weight (yes/no)

Time frame:Baseline (week 0), week 68

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved >=25% reduction of body weight (yes/no)

Time frame:Baseline (week 0), week 68

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved >=5% reduction of BMI (yes/no)

Time frame:Baseline (week 0), week 68

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved >=10% reduction of BMI (yes/no)

Time frame:Baseline (week 0), week 68

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved >=15% reduction of BMI (yes/no)

Time frame:Baseline (week 0), week 68

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved >=20% reduction of BMI (yes/no)

Time frame:Baseline (week 0), week 68

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved >=25% reduction of BMI (yes/no)

Time frame:Baseline (week 0), week 68

≥25% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who achieved normal BMI

Time frame:Baseline (week 0), week 68

threshold achievement, improvement

Secondary/protocol endpoint

Number of participants who shifted from obese to non-obese BMI class

Time frame:Baseline (week 0), week 68

threshold achievement, improvement

Secondary/protocol endpoint

Change in waist circumference

Time frame:Baseline (week 0), week 68 and week 224

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in waist-to-height ratio

Time frame:Baseline (week 0), week 68

change from baseline, improvement

Secondary/protocol endpoint

Absolute change in total fat mass by dual energy X-ray absorption (DXA)

Time frame:Baseline (week 0), week 68

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Relative to baseline change in total fat mass by DXA

Time frame:Baseline (week 0), week 68

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Relative to total body mass change in total fat mass by DXA

Time frame:Baseline (week 0), week 68

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in visceral fat mass by DXA

Time frame:Baseline (week 0), week 68

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Relative to baseline change in visceral fat mass by DXA

Time frame:Baseline (week 0), week 68

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Relative to total body mass change in visceral fat mass by DXA

Time frame:Baseline (week 0), week 68

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Absolute change in lean body mass by DXA

Time frame:Baseline (week 0), week 68

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Relative to total body mass change in lean body mass by DXA

Time frame:Baseline (week 0), week 68

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Absolute change in total (neck-to-knee) muscle and fat volumes by Magnetic Resonance Imaging (MRI) - total muscle and total fat

Time frame:Baseline (week 0), week 68 and week 224

Total fat mass

change from baseline, improvement

componentsLean mass, Total fat mass

Secondary/protocol endpoint

Relative to baseline change in total (neck-to-knee) muscle and fat volumes by MRI - total muscle and total fat

Time frame:Baseline (week 0), week 68 and week 224

Total fat mass

percent change from baseline, improvement

componentsTotal fat mass, Lean mass

Secondary/protocol endpoint

Absolute change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat

Time frame:Baseline (week 0), week 68 and week 224

change from baseline, improvement

Secondary/protocol endpoint

Relative to baseline change in abdominal fat volumes by MRI - subcutaneous fat and visceral fat

Time frame:Baseline (week 0), week 68 and week 224

Visceral fat, change

percent change from baseline, improvement

componentsSubcutaneous fat, change, Visceral fat, change

Secondary/protocol endpoint

Absolute change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat

Time frame:Baseline (week 0), week 68 and week 224

change from baseline, improvement

Secondary/protocol endpoint

Relative to baseline change in thigh muscle and fat volumes by MRI - thigh fat free muscle and thigh subcutaneous fat

Time frame:Baseline (week 0), week 68 and week 224

percent change from baseline, improvement

Secondary/protocol endpoint

Change in BMI percentage of the 95th percentile

Time frame:Baseline (week 0), week 68

change from baseline, improvement

Glycemic / diabetes

10 endpoints
Secondary/protocol endpoint

Change in glycated haemoglobin (HbA1c) (% points)

Time frame:Baseline (week 0), week 68 and week 224

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c (millimoles per mole [mmol/mol])

Time frame:Baseline (week 0), week 68 and week 224

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG) (millimoles per liter [mmol/L])

Time frame:Baseline (week 0), week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in FPG (milligrams per deciliter [mg/dL])

Time frame:Baseline (week 0), week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Ratio to baseline in fasting serum insulin

Time frame:Baseline (week 0), week 68 and week 224

ratio, improvement

Secondary/protocol endpoint

Number of participants with prediabetes who achieved HbA1c less than (<) 5.7% (defined as 5.7 % less than or equal to [<=] HbA1c <6.5 %) at baseline

Time frame:At week 68

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of participants with normoglycemia (defined as HbA1c < 5.7 %) at baseline, development of HbA1c greater than or equal to (>=) 5.7 %

Time frame:At week 68

HbA1c <5.7% achievement

threshold achievement, event

LOINC 4548-4

Secondary/protocol endpoint

Number of participants with prediabetes (5.7 % <= HbA1c < 6.5 %) at baseline, development of HbA1c >= 6.5%

Time frame:At week 68

HbA1c <6.5% achievement

threshold achievement, event

LOINC 4548-4

Secondary/protocol endpoint

Number of participants with HbA1c >=6.5% at baseline, achievement of HbA1c <6.5%

Time frame:At week 68

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of participants taking glucose lowering medication at baseline, stop or decrease

Time frame:Baseline (week 0), week 68

descriptive

MASH / liver

4 endpoints
Secondary/protocol endpoint

Change in ectopic fat content by MRI - liver fat MRI-Proton Density Fat Fraction (MRI-PDFF), pancreatic fat, kidney fat and thigh muscle fat infiltration

Time frame:Baseline (week 0), week 68 and week 224

MRI-PDFF, % change

change from baseline, improvement

Secondary/protocol endpoint

Ratio to baseline in liver stiffness measured by Magnetic Resonance Elastography (MRE)

Time frame:Baseline (week 0), week 68 and week 224

ratio, improvement

Secondary/protocol endpoint

Change in Alanine Transaminase (ALT)

Time frame:Baseline (week 0), week 68 and week 224

ALT, change

change from baseline, improvement

LOINC 1742-6

Secondary/protocol endpoint

Ratio to baseline in liver stiffness measured by ultrasonographic methods

Time frame:Baseline (week 0), week 68 and week 224

Liver stiffness (VCTE), change

ratio, improvement

Cardiometabolic biomarkers

12 endpoints
Secondary/protocol endpoint

Ratio to baseline highly sensitive C-reactive protein (hs-CRP)

Time frame:Baseline (week 0), week 68

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Ratio to baseline in lipids: Total cholesterol

Time frame:Baseline (week 0), week 68 and week 224

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Ratio to baseline in lipids: High Density Lipoprotein (HDL) cholesterol

Time frame:Baseline (week 0), week 68 and week 224

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Ratio to baseline in lipids: Low Density Lipoprotein (LDL) cholesterol

Time frame:Baseline (week 0), week 68 and week 224

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Ratio to baseline in lipids: Very Low Density Lipoprotein (VLDL) cholesterol

Time frame:Baseline (week 0), week 68 and week 224

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Ratio to baseline in lipids: Triglycerides

Time frame:Baseline (week 0), week 68 and week 224

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Ratio to baseline in lipids: Non-HDL cholesterol

Time frame:Baseline (week 0), week 68 and week 224

Non-HDL cholesterol, change

ratio, improvement

Secondary/protocol endpoint

Change in systolic blood pressure

Time frame:Baseline (week 0), week 68 and week 224

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in diastolic blood pressure

Time frame:Baseline (week 0), week 68 and week 224

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Number of participants taking antihypertensive medication at baseline, stop or decrease

Time frame:Baseline (week 0), week 68

descriptive

Secondary/protocol endpoint/low confidence

Number of participants taking lipid lowering medication at baseline, stop or decrease

Time frame:Baseline (week 0), week 68

descriptive

Secondary/protocol endpoint

Change in pulse rate

Time frame:Baseline (week 0), week 68

Heart rate, change

change from baseline, descriptive

Patient-reported / QoL

6 endpoints
Secondary/protocol endpoint

Impact of Weight on Quality of Life-Kids (IWQOL Kids) - Physical comfort domain score

Time frame:Baseline (week 0), week 68 and week 224

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint/low confidence

IWQOL Kids - Body esteem domain score

Time frame:Baseline (week 0), week 68 and week 224

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

IWQOL Kids - Social life domain score

Time frame:Baseline (week 0), week 68 and week 224

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

IWQOL Kids - Family-relations score

Time frame:Baseline (week 0), week 68 and week 224

change from baseline, improvement

Secondary/protocol endpoint

IWQOL Kids - Total score

Time frame:Baseline (week 0), week 68 and week 224

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Control of Eating Questionnaire (COEQ)

Time frame:Baseline (week 0), week 68 and week 224

change from baseline, improvement

Safety / tolerability / PK

7 endpoints
Secondary/protocol endpoint

Number of treatment-emergent adverse events (TEAEs)

Time frame:Baseline (week 0), week 68 and week 224

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment-emergent serious adverse events (TESAEs)

Time frame:Baseline (week 0), week 68 and week 224

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment-emergent hypoglycaemic episodes

Time frame:Baseline (week 0), week 68 and week 224

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Change in calcitonin

Time frame:Baseline (week 0), week 68

Thyroid event

change from baseline, descriptive

Secondary/protocol endpoint

Apparent clearance (CL/F) of semaglutide and cagrilintide at steady state

Time frame:Baseline (week 0), week 68

descriptive

Secondary/protocol endpoint

Average concentration (Cavg) of semaglutide and cagrilintide at steady state

Time frame:Baseline (week 0), week 68

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Area under the steady-state concentration-time curves (AUCt) in the dosing interval of semaglutide and cagrilintide

Time frame:Baseline (week 0), week 68

AUC₀–∞

concentration, descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Change in proteomics-based serum biomarkers including biomarkers for metabolic dysfunction-associated steatohepatitis (MASH)

Time frame:Baseline (week 0), week 68 and week 224

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.