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

Sponsor
Novo Nordisk A/S
Study ID
NCT07411560
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 64 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 9, 2026
Status verified
Apr 2026
Primary completion
Jan 26, 2027
Completion
Jan 26, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide
    Participants will receive low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
  • Experimental: Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide
    Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 2.
  • Experimental: Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide
    Participants will receive high dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.
  • Experimental: Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide
    Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by medium dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 2.

Primary Outcome Measure

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

Central Contacts

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