Cagrilintide trials recruiting now

Who the trial lists, as registered

Lists people 8 to 18. Conditions: Overweight; Obesity.

• Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study related activities.
• 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.

27 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Cagrilintide; Semaglutide; Placebo cagrilintide; Placebo semaglutide

Registered summary

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. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. The full summary is on the listing.

Where, as registered

34 US sites in 19 states; also China (9), India (9), Bulgaria (4), Israel (4), Italy (4), Poland (4), Romania (4), Slovakia (4), Taiwan (4), Australia (3), Croatia (3), Hungary (3), Malaysia (3), Mexico (3), Portugal (3), Serbia (3), Spain (3), United Kingdom (3), Austria (2), Belgium (2), Colombia (2), Denmark (2), Netherlands (2), Sweden (2), Thailand (2).

Who the trial lists, as registered

Lists people 10 to 18. Conditions: Diabetes Mellitus, Type 2.

• Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities.
• 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.

18 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

CagriSema (Cagrilintide B and Semaglutide I); Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Registered summary

The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.

Where, as registered

21 US sites in 14 states; also India (9), Brazil (6), Argentina (5), Israel (5), Mexico (5), Colombia (2), Malaysia (2), Thailand (2), Taiwan (1).

Who the trial lists, as registered

Lists people 18 and older. Conditions: Obesity; Overweight.

• Male or female (sex at birth)
• Age 18 years or above at the time of signing the informed consent
• History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation
• Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement

7 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Cagrilintide; Placebo (matched to Cagrilintide)

Registered summary

The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.

Where, as registered

13 US sites in 7 states.

Who the trial lists, as registered

Lists people 18 and older. Conditions: Overweight; Obesity.

• Informed consent 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.
• Male or female (sex assigned at birth, inclusive of all gender identities).
• Age 18 years or above at the time of signing the informed consent.
• Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per square meter (kg/m\^2), or BMI >= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia,…

The exclusion criteria are on the listing.

What it tests, as registered

Cagrilintide; Placebo cagrilintide; Placebo semaglutide

Registered summary

The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.

Where, as registered

11 US sites in 8 states; also Greece (6), Portugal (6), Serbia (5), Hungary (4), Sweden (4).

Who the trial lists, as registered

Lists people 18 to 64. Conditions: Obesity; Overweight.

• Aged 18-64 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the…

The exclusion criteria are on the listing.

What it tests, as registered

Cagrilintide D; Cagrilintide B and placebo semaglutide I

Registered summary

This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 months.

Where, as registered

No US site; Germany (1).

Who the trial lists, as registered

Lists female participants 50 to 70. Conditions: Obesity.

• Female.
• Post-menopausal at screening (defined as minimum 12 months of amenorrhea, high levels of follicular stimulating hormone (FSH) 16 - 130 international units per liter (IU/L), and low levels of anti-müllerian hormone (AMH) and inhibin B).
• Age 50-70 years (both inclusive) at the time of signing the informed consent.
• Body Mass Index (BMI) greater than or equal to >= 30.0 kilograms per square meter (kg/m\^2).

The exclusion criteria are on the listing.

What it tests, as registered

Cagrilintide; Semaglutide; Placebo cagrilintide; Placebo semaglutide

Registered summary

In this study we will investigate how the medicine cagrilintide affects bone health in women after menopause with obesity during weight loss, compared to treatment with placebo (the dummy medicine with no active substances) and semaglutide. The purpose is to examine whether cagrilintide can reduce the decline in bone mass associated to weight loss. Participants will either get cagrilintide, semaglutide, CagriSema (cagrilintide combined with semaglutide) or placebo. Which treatment participants get is decided by chance. The full summary is on the listing.

Where, as registered

No US site; Denmark (1).

Who the trial lists, as registered

Lists people 18 to 64. Conditions: Overweight; Obesity.

• Male or female (sex at birth).
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m\^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.
• Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit,…

The exclusion criteria are on the listing.

What it tests, as registered

Cagrilintide; Placebo Cagrilintide

Registered summary

The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.

Where, as registered

No US site; Germany (1).

Who the trial lists, as registered

Lists female participants 18 to 64. Conditions: Overweight; Obese.

• Female at birth.
• Age 18-64 years (both inclusive) at the time of signing the informed consent.
• Body mass index (BMI) between 27.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening.
• Overweight should be due to excess adipose tissue, as judged by the investigator.

2 more inclusion criteria and the exclusion criteria are on the listing.

What it tests, as registered

Glucose-dependent Insulinotropic Polypeptide (GIP); Cagrilintide; Placebo GIP

Registered summary

This trial is being done to look at the safety and effect of combining cagrilintide and NNC0480-0389 in people living with overweight and obesity compared to taking cagrilintide alone. In one period participants will get two medicines: cagrilintide and NNC0480-0389. In the other period, participants will get cagrilintide together with a placebo version of NNC0480-0389.The placebo looks like the real treatment but does not have any active medicine in it. Cagrilintide and NNC0480-0389 is a new medicine being tested to help people with type 2 diabetes and/or overweight or obesity. The full summary is on the listing.

Where, as registered

No US site; United Kingdom (1).

Who the trial lists, as registered

Lists people 50 to 70. Conditions: Obesity.

• Male or female.
• Age 50-70 years (both inclusive) at the time of signing the informed consent.
• Body Mass index (BMI) between 30.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening (V1).
• Excess body weight should be due to excess adipose tissue, as judged by the investigator.

1 more inclusion criterion and the exclusion criteria are on the listing.

What it tests, as registered

Cagrilintide; Semaglutide; Placebo cagrilintide; Placebo semaglutide

Registered summary

The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight. Participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to treat people with type 2 diabetes and excess body weight) or placebo (a placebo looks like the treatment being tested but doesn't have any active ingredients in it). The full summary is on the listing.

Where, as registered

No US site; Denmark (1).