Obesity / Cagrilintide / Overweight · Phase 3 Trial

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

ClinicalTrials.gov · August 3, 2026

Preliminary Why this matters to you Expert discussion

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

AI Summary

This is an active Phase 3 randomized controlled trial comparing cagrilintide to placebo in people with overweight/obesity and type 2 diabetes. The study measures relative change in body weight over 64 weeks of treatment. No results are posted in this registry record; the trial is currently recruiting or active but not enrolling.

What was studied

Phase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Overweight, Obesity, Type 2 Diabetes; age from 18 Years. Intervention: Cagrilintide. Compared with: Placebo — Placebo Comparator. n = 330. 67 sites across 11 countries.

Key findings

Safety

This is a registry record with no posted results; no outcome data, effect sizes, or safety findings are reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is an active Phase 3 RCT registration with no posted results; the study design and planned enrollment are reported but outcomes remain unknown.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Relative change in body weight (assessed at From baseline (week 0) to end of treatment (week 64))

DesignPhase 3, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationOverweight, Obesity, Type 2 Diabetes; age from 18 Years

Sample size330

InterventionCagrilintide

ComparatorPlacebo — Placebo Comparator

Setting67 sites across 11 countries

Reported figures

Quoted from the source exactly as published.

Planned enrollment330

PhasePHASE 3

Primary outcome measureRelative change in body weight from baseline (week 0) to end of treatment (week 64)

Randomization ratio2:1 cagrilintide:placebo

Study duration per participantapproximately 1 year and 6 months

Caveats

This is a registry record with no posted results; no outcome data, effect sizes, or safety findings are reported.
Eligibility criteria, detailed inclusion/exclusion, and comparator dosing not stated in registry text.
Final analyzed sample size not reported; only estimated enrollment of 330 provided.
No information on whether blinding, allocation concealment, or statistical analysis plan details are documented.

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

strong

Phase 3, randomized, placebo-controlled, interventional trial design clearly stated.

Directness

strong

Primary outcome directly addresses weight loss in target population with relevant conditions.

Consistency

insufficient

Registry record contains no results; consistency cannot be assessed.

Risk of bias

moderate

Randomization and placebo control present; allocation ratio 2:1 cagrilintide:placebo stated.

Sample adequacy

moderate

Estimated 330 participants enrolled; final sample and power analysis not stated in registry.

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 (NCT07220759). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 330 participants (ESTIMATED). Conditions: Overweight, Obesity, Type 2 Diabetes. Interventions: DRUG: Cagrilintide; DRUG: Placebo (matched to Cagrilintide). Primary outcome measures: Relative change in body weight , From baseline (week 0) to end of treatment (week 64). Brief summary: This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

Follow from this

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

ObesityCagrilintideOverweightNovo NordiskPlacebo (matched to Cagrilintide)NCT07220759Type 2 Diabetes