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New treatment option for Overweight
Official title A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
ClinicalTrials.gov ID: NCT07253285
What this study is testing
What is Cagrilintide?
Cagrilintide is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for overweight.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 18
You may be able to join if
- Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any...
- 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.
You likely can't join if
- 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.
See the full 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...
- 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...
- 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 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Escondido, California, United States
- Hollywood, Florida, United States
- Jacksonville, Florida, United States
- Weston, Florida, United States
- Atlanta, Georgia, United States
- Columbus, Georgia, United States
- Decatur, Georgia, United States
- Snellville, Georgia, United States
- Meridian, Idaho, United States
- Indianapolis, Indiana, United States
- Topeka, Kansas, United States
- Baton Rouge, Louisiana, United States
- Baltimore, Maryland, United States
- Minneapolis, Minnesota, United States
- Richfield, Minnesota, United States
- Buffalo, New York, United States
- Syracuse, New York, United States
- The Bronx, New York, United States
- Fargo, North Dakota, United States
- Columbus, Ohio, United States
+ 89 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Escondido, California, United States; Hollywood, Florida, United States; Jacksonville, Florida, United States; Weston, Florida, United States; Atlanta, Georgia, United States; Columbus, Georgia, United States and 103 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.