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A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese

ConditionsOverweightObese
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age18-64
SponsorNovo Nordisk A/S

About this trial

This trial is being done to look at the safety and effect of combining cagrilintide and NNC0480-0389 in people living with overweight and obesity compared to taking cagrilintide alone. In one period participants will get two medicines: cagrilintide and NNC0480-0389. In the other period, participants will get cagrilintide together with a placebo version of NNC0480-0389.The placebo looks like the real treatment but does not have any active medicine in it. Cagrilintide and NNC0480-0389 is a new medicine being tested to help people with type 2 diabetes and/or overweight or obesity. The trial medicines is not yet approved for use outside of clinical trials. Participants will receive the trial medicines the way the trial doctor has described. The study will last for about 4.5 months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female at birth.

Age 18-64 years (both inclusive) at the time of signing the informed consent.

Body mass index (BMI) between 27.0 kilograms per square meter (kg/m²) and 39.9 kg/m² (both inclusive) at screening.

Overweight should be due to excess adipose tissue, as judged by the investigator.

Disqualifiers

Known or suspected hypersensitivity to study intervention(s) or related products.

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.

Current participation (i.e., dosing) in any other interventional clinical study within 90 days before screening.

Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Trial design

Design model

Crossover

Treatments tested in this trial

  • Glucose-dependent Insulinotropic Polypeptide (GIP)

    Drug

    Participants will receive GIP subcutaneously.

  • Cagrilintide

    Drug

    Participants will receive Cagrilintide subcutaneously.

  • Placebo GIP

    Drug

    Participants will receive placebo matched to GIP subcutaneously.

Treatment groups

100 Participants
are divided into 4 treatment groups
Group A: Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+CagrilintideExperimental treatment 3 interventions
Group B: Arm 2: Placebo GIP + Cagrilintide then GIP + CagrilintideExperimental treatment 3 interventions
Group C: Arm 3: GIP + Cagrilintide then Placebo GIP + CagrilintideExperimental treatment 3 interventions
Group D: Arm 4: Placebo GIP + Cagrilintide then GIP + CagrilintideExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea

Measured as number of events.

Time frame
From first investigational medicinal products (IMP) administration (visit 2, day 1 or visit 9, day 74) to the end of treatment visit (Visit 2, day 16 or Visit 9, day 89)

Secondary outcomes

1

Total number of Adverse Events

Measured as number of events.

Time frame
First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novo Nordisk A/S

Lead sponsor

Source ClinicalTrials.gov
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