Obesity / Cagrilintide / Placebo semaglutide · Phase 1 Trial

The Role of the Amylin Analogue Cagrilintide in Bone Metabolism

ClinicalTrials.gov · September 10, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 registry record for a randomized, placebo-controlled trial of cagrilintide, a novel amylin analogue, in postmenopausal women with obesity. The study aims to assess whether cagrilintide mitigates bone mineral density loss during weight loss, measured by quantitative computed tomography of the hip at week 68. No results are yet reported in this registry entry.

What was studied

Phase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity; Female; age from 50 Years; to 70 Years. Intervention: Cagrilintide; Semaglutide; CagriSema. Compared with: Placebo — Placebo Comparator. n = 144. 1 site: Denmark.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

This trial will provide early safety and efficacy signals for a novel agent in bone metabolism during obesity treatment and weight loss. Results are not yet available to inform clinical practice.

Plain-language summary

Phase 1 interventional trial in recruitment examining a novel agent (cagrilintide) on a surrogate bone metabolism endpoint; no results reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT) (assessed at From baseline to end of treatment (week 68))

DesignPhase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationObesity; Female; age from 50 Years; to 70 Years

Sample size144

InterventionCagrilintide; Semaglutide; CagriSema

ComparatorPlacebo — Placebo Comparator

Setting1 site: Denmark

Reported figures

Quoted from the source exactly as published.

Planned enrollment144

Study phasePhase 1

Primary outcome measureRelative change in volumetric bone mineral density (vBMD) of total hip by QCT from baseline to week 68

Study duration79 weeks

Clinical bottom line

This trial will provide early safety and efficacy signals for a novel agent in bone metabolism during obesity treatment and weight loss. Results are not yet available to inform clinical practice.

Caveats

This is a registry record; no results have been posted or published.
Phase 1 trial; findings are preliminary and require confirmation in later-phase trials.
Primary outcome is a surrogate marker (bone mineral density); clinical fracture outcomes not assessed.
Enrollment status is 'recruiting'; study completion and outcome data collection are not yet complete.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized, placebo-controlled, Phase 1 interventional design with multiple arms.

Directness

limited

Primary outcome is volumetric bone mineral density, a surrogate; clinical fracture or bone health outcomes not stated.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

moderate

Randomized and placebo-controlled design; blinding and conduct details not provided in registry text.

Sample adequacy

limited

Estimated enrollment 144 participants for Phase 1; adequacy for bone endpoints unclear.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07010432). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 144 participants (ESTIMATED). Conditions: Obesity. Interventions: DRUG: Cagrilintide; DRUG: Semaglutide; DRUG: Placebo cagrilintide; DRUG: Placebo semaglutide. Primary outcome measures: Relative change in volumetric bone mineral density (vBMD) of the total hip assessed by quantitative computed tomography (QCT) , From baseline to end of treatment (week 68). Brief 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. 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ObesityCagrilintideNovo NordiskPlacebo semaglutidePlacebo cagrilintideSemaglutideNCT07010432