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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 months

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last for about 8 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of cagrilintide compared with a placebo, which has no active medicine. It is for adults with obesity who stopped GLP-1 medicines because of stomach or bowel side effects. Treatment is chosen by chance, and the study lasts about 8 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 or older.
  • Male or female, based on sex at birth.
  • Have records showing you stopped GLP-1 medicines mainly because of stomach or bowel side effects.
  • The study doctor decides that restarting GLP-1 medicines is not suitable based on your medical history.
  • Have a body mass index (BMI) of 30 or higher. BMI is a measure of weight compared with height.

Who can't join

  • Are pregnant, breastfeeding, or planning to become pregnant, or can become pregnant but are not using highly effective birth control.
  • Used a GLP-1 medicine within 8 weeks before screening.
  • Have a history of type 1 or type 2 diabetes.
  • Have an HbA1c of 6.5% or higher on the screening blood test. This test measures average blood sugar.
  • Used medicine to lower blood sugar for diabetes or prediabetes within 90 days before screening.
  • Used any medicine prescribed for weight control within 8 weeks before screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (13)

CA

FL

GA

NC

SC

TN

TX