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AzTrials

ObesityPhase 1RAMBONCT07010432

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

A Phase 1 study testing Cagrilintide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 years, women only
Conditions the study is for
Obesity
What is being tested?
Cagrilintide and Semaglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
144 participants
Where
1 siteDenmark
Study dates
12 Jun 2025to 3 May 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Novo Nordisk contact

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Denmark1 site, 1 recruiting

  • Steno Diabetes Center Copenhagen

    Herlev, 2730

    Recruiting

Other trials in Denmark

About this study

Official title: The Role of the Amylin Analogue Cagrilintide in Bone Metabolism During Weight Loss in Postmenopausal Women With Obesity

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.

Conditions
Obesity
Being tested
Cagrilintide, Semaglutide, Placebo cagrilintide, Placebo semaglutide
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CagrilintideDrug

    Participants will receive once-weekly cagrilintide subcutaneously.

  • SemaglutideDrug

    Participants will receive once-weekly semaglutide subcutaneously.

  • Placebo cagrilintideDrug

    Participants will receive once-weekly placebo matched to cagrilintide subcutaneously.

  • Placebo semaglutideDrug

    Participants will receive once-weekly placebo matched to semaglutide subcutaneously.

Study groups in NCT07010432
Study groupRoleWhat they receive
CagrilintideExperimentalParticipants 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.
Receives: Drug: Cagrilintide; Drug: Placebo cagrilintide
SemaglutideExperimentalParticipants 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.
Receives: Drug: Semaglutide; Drug: Placebo semaglutide
CagriSemaExperimentalParticipants 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.
Receives: Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo cagrilintide; Drug: Placebo semaglutide
PlaceboPlacebo comparatorParticipants will receive once-weekly s.c injection of placebo matched to semaglutide and cagrilintide for 68 weeks.
Receives: Drug: Placebo cagrilintide; Drug: Placebo semaglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT)

    Measured in percentage (%).

    Measured: From baseline to end of treatment (week 68)

Secondary outcomes (13)

  1. Relative changes in vBMD of the lumbar 1 (L1) - L4 vertebrae assessed by QCT

    Measured in %.

    Measured: From baseline to end of treatment (week 68)

  2. Relative changes in vBMD of the radius assessed by QCT

    Measured in %.

    Measured: From baseline to end of treatment (week 68)

  3. Relative changes in vBMD of the L1 - L4 vertebrae assessed by QCT

    Measured in %.

    Measured: From baseline to week 20

  4. Relative changes in vBMD of the radius assessed by QCT

    Measured in %.

    Measured: From baseline to week 20

  5. Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - positron emission tomography (PET)

    Measured in %.

    Measured: From baseline to end of treatment (week 68)

  6. Relative change in the Ki (bone turnover) of the femoral neck assessed by fluoride - PET

    Measured in %.

    Measured: From baseline to week 20

  7. Relative changes in C-terminal telopeptide of type I collagen (CTX-1) and procollagen type 1 N-terminal propeptide (P1NP)

    Measured in %.

    Measured: From baseline to end of treatment (week 68)

  8. Relative changes in CTX-1 and P1NP

    Measured in %.

    Measured: From baseline to week 20

  9. Relative changes in cortical thickness and porosity assessed by photon-counting computed tomography (PCCT)

    Measured in %.

    Measured: From baseline to end of treatment (week 68)

  10. Relative changes in trabecular thickness assessed by PCCT

    Measured in %.

    Measured: From baseline to end of treatment (week 68)

  11. Relative changes in number and separation of the femoral neck assessed by PCCT

    Measured in %.

    Measured: From baseline to end of treatment (week 68)

  12. Relative changes in L1-L2 vertebrae assessed by PCCT

    Measured in %.

    Measured: From baseline to end of treatment (week 68)

  13. Relative changes in radius assessed by PCCT

    Measured in %.

    Measured: From baseline to end of treatment (week 68)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jun 2025
  2. Study start12 Jun 2025
  3. Primary completion3 May 2028 (estimated)
  4. Study completion3 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07010432
Sponsor's protocol ID
NN9388-8175
Other IDs
U1111-1313-0864, 2024-517883-49
Acronym
RAMBO
Status last verified
Sep 2026
First submitted
30 May 2025
Last updated
10 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cagrilintide and Semaglutide in people with Obesity, run by Novo Nordisk A/S at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT) (time frame: From baseline to end of treatment (week 68)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07010432.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.

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