OverweightPhase 1NCT07411560
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
A Phase 1 study testing Glucose-dependent Insulinotropic Polypeptide (GIP) and Cagrilintide in people with Overweight and Obese, run by Novo Nordisk A/S at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years, women only
- Conditions the study is for
- Overweight, Obese
- What is being tested?
- Glucose-dependent Insulinotropic Polypeptide (GIP) and Cagrilintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2026to 26 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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:
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Parexel Research Unit
Harrow, Middlesex, HA1 3UJ
About this study
Official title: 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.
- Conditions
- Overweight, Obese
- Being tested
- Glucose-dependent Insulinotropic Polypeptide (GIP), Cagrilintide, Placebo GIP
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucose-dependent Insulinotropic Polypeptide (GIP)Drug
Participants will receive GIP subcutaneously.
CagrilintideDrug
Participants will receive Cagrilintide subcutaneously.
Placebo GIPDrug
Participants will receive placebo matched to GIP subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Glucose-dependent Insulinotropic Polypeptide (GIP); Drug: Cagrilintide; Drug: Placebo GIP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea
Measured as number of events.
Measured: 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
Measured as number of events.
Measured: First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start9 Feb 2026
- Primary completion26 Jan 2027 (estimated)
- Study completion26 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07411560
- Sponsor's protocol ID
- EX0700-8445
- Other IDs
- U1111-1324-3573
- Status last verified
- Apr 2026
- First submitted
- 9 Feb 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07411560
- Acronym / sponsor ID
- EX0700-8445
- Conditions
- Overweight, Obese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Feb 2026 (actual)
- Primary completion
- 26 Jan 2027 (estimated)
- Study completion
- 26 Jan 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide | Experimental | Drug: Glucose-dependent Insulinotropic Polypeptide (GIP), Drug: Cagrilintide, Drug: Placebo GIPParticipants 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. |
| Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide | Experimental | Drug: Glucose-dependent Insulinotropic Polypeptide (GIP), Drug: Cagrilintide, Drug: Placebo GIPParticipants 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. |
| Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide | Experimental | Drug: Glucose-dependent Insulinotropic Polypeptide (GIP), Drug: Cagrilintide, Drug: Placebo GIPParticipants 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. |
| Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide | Experimental | Drug: Glucose-dependent Insulinotropic Polypeptide (GIP), Drug: Cagrilintide, Drug: Placebo GIPParticipants 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. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glucose-dependent Insulinotropic Polypeptide (GIP)Participants will receive GIP subcutaneously. | Drug | 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 |
| CagrilintideParticipants will receive Cagrilintide subcutaneously. | Drug | 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 GIPParticipants will receive placebo matched to GIP subcutaneously. | Drug | 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 |
Primary outcome
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)
Measured as number of events.
1 secondary outcome
Total number of Adverse Events
Time frame: First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Transparency (dept. 2834) study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glucose-dependent Insulinotropic Polypeptide (GIP) and Cagrilintide in people with Overweight and Obese, run by Novo Nordisk A/S at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Novo Nordisk ((+1) 866-867-7178, clinicaltrials@novonordisk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.