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

NCT07411560 | Recruiting Phase 1

• 2 other identifiers: EX0700-8445U1111-1324-3573
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obese

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Total number of Adverse Events

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

Study Arms (4)

Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide

EXPERIMENTAL

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: Glucose-dependent Insulinotropic Polypeptide (GIP); Drug: Cagrilintide; Drug: Placebo GIP

Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide

EXPERIMENTAL

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: Glucose-dependent Insulinotropic Polypeptide (GIP); Drug: Cagrilintide; Drug: Placebo GIP

Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide

EXPERIMENTAL

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: Glucose-dependent Insulinotropic Polypeptide (GIP); Drug: Cagrilintide; Drug: Placebo GIP

Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide

EXPERIMENTAL

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: Glucose-dependent Insulinotropic Polypeptide (GIP); Drug: Cagrilintide; Drug: Placebo GIP

Interventions

Cagrilintide DRUG

Participants will receive Cagrilintide subcutaneously.

Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide; Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide; Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide; Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide

Placebo GIP DRUG

Participants will receive placebo matched to GIP subcutaneously.

Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide; Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide; Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide; Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide

Glucose-dependent Insulinotropic Polypeptide (GIP) DRUG

Participants will receive GIP subcutaneously.

Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide; Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide; Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide; Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Parexel Research Unit

Harrow, Middlesex, HA1 3UJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Interventions

Incretins; cagrilintide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: February 9, 2026
• Primary Completion (Estimated): January 26, 2027
• Study Completion (Estimated): January 26, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)