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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Overweight; Obese
• Intervention / Treatment: Drug: Cagrilintide; Drug: Glucose-dependent Insulinotropic Polypeptide (GIP); Drug: Placebo GIP

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• United Kingdom
  • Middlesex
    • Harrow, Middlesex, United Kingdom, HA1 3UJ
      • Recruiting
      • Parexel Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, including incretin-based treatment(s).

• Previous or planned (during the study period) obesity treatment with surgery. However, the following are allowed:

  1. Liposuction and/or abdominoplasty, if performed greater than symbol (>) 1 year before screening.
  2. Adjustable gastric banding, if the band has been removed > 1 year before screening.
  3. Intragastric balloon, if the balloon has been removed > 1 year before screening.
  4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed > 1 year before screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Cagrilintide; Participants will receive Cagrilintide subcutaneously.; Drug: Glucose-dependent Insulinotropic Polypeptide (GIP); Participants will receive GIP subcutaneously.; Drug: Placebo GIP; Participants will receive placebo matched to GIP subcutaneously.
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.	Drug: Cagrilintide; Participants will receive Cagrilintide subcutaneously.; Drug: Glucose-dependent Insulinotropic Polypeptide (GIP); Participants will receive GIP subcutaneously.; Drug: Placebo GIP; Participants will receive placebo matched to GIP subcutaneously.
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.	Drug: Cagrilintide; Participants will receive Cagrilintide subcutaneously.; Drug: Glucose-dependent Insulinotropic Polypeptide (GIP); Participants will receive GIP subcutaneously.; Drug: Placebo GIP; Participants will receive placebo matched to GIP subcutaneously.
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.	Drug: Cagrilintide; Participants will receive Cagrilintide subcutaneously.; Drug: Glucose-dependent Insulinotropic Polypeptide (GIP); Participants will receive GIP subcutaneously.; Drug: Placebo GIP; Participants will receive placebo matched to GIP subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea	Measured as number of events.	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total number of Adverse Events	Measured as number of events.	First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2026
• Primary Completion (Estimated): January 26, 2027
• Study Completion (Estimated): January 26, 2027

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pharmacologic Actions; Chemical Actions and Uses; Incretins; cagrilintide
• Other Study ID Numbers: EX0700-8445; U1111-1324-3573 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No