Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events

Tolerability of Cagrilintide in People With Obesity That Discontinued GLP-1-RA Therapies Due to Gastrointestinal Adverse Events: a Double-blinded Randomised Feasibility Study

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07607587

Enrollment

114

Registered

2026-05-26

Start date

2026-05-29

Completion date

2027-11-19

Last updated

2026-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

Brief 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.

Interventions

DRUGCagrilintide

Cagrilintide will be administered subcutaneously.

DRUGPlacebo (matched to Cagrilintide)

Placebo matched to Cagrilintide will be administered subcutaneously.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * 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 * Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m\^2) Key

Exclusion criteria

* Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods * Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening * History of type 1 or type 2 diabetes * Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole \[mmol/mol\]) as measured by the central laboratory at screening * Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening * Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening

Design outcomes

Primary

Measure	Time frame	Description
Percentage of participants on standard dose or higher dose (yes/no) of cagrilintide and placebo	At week 26	Measured as percentage of participants.

Countries

United States

Contacts

CONTACTNovo Nordisk

clinicaltrials@novonordisk.com(+1) 866-867-7178

STUDY_DIRECTORClinical Transparency (dept. 2834)

Novo Nordisk A/S

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 26, 2026