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Single-centre Study Investigating the Role of Long-acting Subcutaneous Glucose-dependent Insulinotropic Polypeptide Receptor Agonist (GIP RA) in Combination With Long-acting Subcutaneous Amylin Receptor Agonist on Gastrointestinal Tolerability in Participants With Overweight or Obesity
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 64
Healthy Volunteers: f
View:
• 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/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening.
• Overweight should be due to excess adipose tissue, as judged by the investigator.
• Considered eligible with suitable veins for cannulation or repeated venepuncture, as judged by the investigator.
• No clinically significant findings during medical history, physical examination, vital signs, electrocardiogram or clinical laboratory tests at the screening visit, as assessed by the investigator.
Locations
Other Locations
United Kingdom
Parexel Research Unit
RECRUITING
Harrow
Contact Information
Primary
Novo Nordisk
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Time Frame
Start Date:2026-02-09
Estimated Completion Date:2027-01-26
Participants
Target number of participants:100
Treatments
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.