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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorNovo Nordisk A/S

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cagrilintide

    Drug

    Cagrilintide will be administered subcutaneously.

  • Placebo (matched to Cagrilintide)

    Drug

    Placebo matched to Cagrilintide will be administered subcutaneously.

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: CagrilintideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percentage of participants on standard dose or higher dose (yes/no) of cagrilintide and placebo

Measured as percentage of participants.

Time frame
At week 26

Secondary outcomes

Other outcomes

Sponsors and contacts

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