The Role of the Amylin Analogue Cagrilintide in Bone Metabolism (RAMBO)

Novo Nordisk

Status and phase: Not yet enrolling; Phase 1

Conditions: Obesity

Treatments: Drug: Placebo cagrilintide; Drug: Placebo semaglutide; Drug: Semaglutide; Drug: Cagrilintide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07010432

2024-517883-49 (Other Identifier)

NN9388-8175

U1111-1313-0864 (Other Identifier)

Details and patient eligibility

About

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. Semaglutide is already approved for the treatment of overweight and obesity and can be prescribed by doctors. Cagrilintide and CagriSema are new medications currently under development for weight management. The study will last for about 79 weeks.

Enrollment: 144 estimated patients

Sex: Female

Ages: 50 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• 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).

Exclusion criteria

• Previous or current bone disease (e.g., osteoporosis, Paget's disease of bone, or bone cancer).
• Presence of disease affecting bone metabolism (e.g., diabetes mellitus, hyperparathyroidism, hyper or hypothyroidism, chronic kidney disease, celiac disease, or inflammatory diseases (e.g., psoriatic arthritis or ankylosing spondylitis)).
• Treatment with any medication affecting bone metabolism within 6 months prior to screening as judged by the investigator (e.g., anti-resorptive medication, anabolic medication, systemic hormone replacement therapy (HRT), or systemic corticosteroids).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 4 patient groups, including a placebo group

Cagrilintide

Experimental group

Description:

Participants will receive once-weekly subcutaneous (s.c) injections of cagrilintide or placebo at stepwise doses every 4 weeks in a 16-week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.

Treatment:

Drug: Cagrilintide

Drug: Placebo cagrilintide

Semaglutide

Experimental group

Description:

Participants will receive once-weekly s.c injections of semaglutide or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.

Treatment:

Drug: Placebo semaglutide

Drug: Semaglutide

CagriSema

Experimental group

Description:

Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) or placebo at stepwise doses every 4 weeks in a 16 week dose escalation period until target dose is achieved and maintained for 52 weeks as adjunct to a reduced calorie diet.

Treatment:

Drug: Cagrilintide

Drug: Placebo semaglutide

Drug: Semaglutide

Drug: Placebo cagrilintide

Placebo

Placebo Comparator group

Description:

Participants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 68 weeks.

Treatment:

Drug: Placebo semaglutide

Drug: Placebo cagrilintide