RecruitingPHASE1INTERVENTIONAL

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

This study, called a Phase 1 trial, is looking at a new treatment approach for adults who are overweight or obese. Researchers want to see if combining two hormones – GIP and Amylin – given as weekly injections, might lead to fewer stomach-related side effects compared to taking only one of the hormones. Participants will receive both medicines in one period and then one medicine with a look-alike dummy treatment (placebo) in another. Both GIP and Amylin (cagrilintide and NNC0480-0389) are currently experimental medicines, not yet approved for general use. The study aims to understand their safety and how well they are tolerated over roughly 4.5 months.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

Novo Nordisk A/S

Enrolment target

100

Start

09 Feb 2026

Estimated completion

26 Jan 2027

Overweight Obese

What is this study about?

This study is a Phase 1 clinical trial, which means it's one of the first steps in testing a new treatment. The main goal is to check the safety of a new combination of two medicines, called cagrilintide and NNC0480-0389. These are types of hormones, specifically GIP and Amylin, that doctors are exploring to help people who are overweight or obese.

The researchers want to see how these two hormones work together and if combining them might help reduce some of the stomach-related side effects that can sometimes occur with these types of treatments, compared to taking cagrilintide on its own. It's important to remember that these medicines are still in the testing phase and are not yet available for general use outside of clinical trials.

Participants will spend some time taking both cagrilintide and NNC0480-0389, and another period taking cagrilintide along with a 'placebo' version of NNC0480-0389. A placebo looks exactly like the real medicine but contains no active ingredients. This helps researchers understand the true effects of the NNC0480-0389 when combined with cagrilintide. The entire study period is expected to last for about 4 and a half months.

Key takeaways

Tests a new combination of two hormones (GIP and Amylin) for overweight/obesity.
Aims to reduce stomach side effects compared to one hormone alone.
Involves weekly injections for about 4.5 months.
Exclusively for women aged 18-64 who are overweight or obese.
Study medicines are experimental and not yet approved.

Who may be eligible?

This study is looking for women who are between 18 and 64 years old. To be considered, you should have a Body Mass Index (BMI) between 27.0 and 39.9, meaning you are classified as overweight or obese due to extra body fat, as determined by the study doctor. You also need to be generally healthy, as confirmed by medical checks, and have veins suitable for injections or blood tests.

There are several reasons why you might not be able to join. These include having an allergy to any of the study medicines or similar products. You cannot be pregnant, breastfeeding, planning to become pregnant, or capable of becoming pregnant without using highly effective birth control. You also can't be currently taking part in another clinical study or have done so in the last 90 days.

Additionally, you would be excluded if the study doctor thinks participation might put your safety at risk or make it hard for you to follow the study rules. You shouldn't have taken any medication for weight loss in the last 90 days, including certain diabetes medicines. Past weight loss surgery is generally not allowed unless specific conditions (like liposuction or gastric band removal) were done more than a year ago.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you female and between 18 and 64 years old?
Is your BMI between 27.0 and 39.9?
Are you generally healthy and not currently pregnant or breastfeeding?
Have you avoided other weight-loss medications or clinical studies in the last 90 days?
Have you not had weight loss surgery recently (check study details for specifics)?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive weekly injections of the study medicines, either the combined treatment or one medicine with a placebo. The study doctor will explain exactly how to take them. You'll have regular appointments for medical checks, blood tests, and to discuss any side effects you might be experiencing. The study will involve two main treatment periods, and you'll switch between receiving both active medicines and one active medicine with a placebo. The total time you'd be involved in the study, including all visits and follow-ups, will be roughly 4 and a half months.

Potential risks and benefits

While participating in this study could offer useful information for future treatments for overweight and obesity, there's no guarantee that you will personally benefit. You might experience side effects from the study medicines, such as stomach issues, or have reactions at the injection site. All potential risks will be thoroughly explained before you decide to join. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Parexel Research Unit
Verified postcode
Harrow, United Kingdom· Recruiting

Common questions

What is a 'Phase 1' study?

Phase 1 is the earliest stage of testing new medicines in people. It mainly focuses on whether the treatment is safe and tolerable, rather than how effective it is.

What is a placebo?

A placebo is a 'dummy' treatment that looks like the real medicine but doesn't contain any active ingredients. It helps researchers compare the effects of the active medicine to no treatment.

Are the study medicines approved for use?

No, both cagrilintide and NNC0480-0389 are experimental medicines and are not yet approved for general use outside of clinical trials.

How long will I be in the study?

The study will last for approximately 4.5 months in total, including all appointments and treatment periods.

Can men join this study?

No, this particular study is only recruiting women.

How to find out more

Novo Nordisk

clinicaltrials@novonordisk.com (+1) 866-867-7178 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.