ObesityPhase 1NCT07607587
Evaluation of the Tolerability of Cagrilintide in Participants Not Tolerating GLP-1-RA Therapies Due to Gastrointestinal Adverse Events
A Phase 1 study testing Cagrilintide in people with Obesity and Overweight, run by Novo Nordisk A/S at 13 sites in United States.
Trial summary
The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Overweight
- What is being tested?
- Cagrilintide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 13 sitesUnited States
- Study dates
- 29 May 2026to 19 Nov 2027
- Phase
- Phase 1
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female (sex at birth)
- Age 18 years or above at the time of signing the informed consent
- History of documented treatment with GLP-1-RA medications with gastrointestinal (GI) adverse effects as the main reason for treatment discontinuation
- Not suitable for re-initiation of GLP-1-RA treatment based on medical history and investigator judgement
- Body mass index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m^2)
Who cannot join
- Female who is pregnant, breast-feeding, or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive methods
- Treatment with GLP-1 receptor agonist or GLP-1-RA medication for any indication within 8 weeks before screening
- History of type 1 or type 2 diabetes
- Glycated haemoglobin (HbA1c) ≥ 6.5 percent (%) (48 millimole per mole [mmol/mol]) as measured by the central laboratory at screening
- Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening
- Treatment with any medication prescribed for the indication of weight management within 8 weeks before screening
Trial locations and contacts
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
United States13 sites, 13 recruiting
- Recruiting
Amarillo Medical Specialists
Amarillo, Texas, 79124
- Recruiting
Elligo Clin Res Centre
Austin, Texas, 78704
- Recruiting
Holston Medical Group_Bristol
Bristol, Tennessee, 37620
- Not yet recruiting
Hope Clin Res & Wellness
Conyers, Georgia, 30094
- Recruiting
Northeast Research Institute
Fleming Island, Florida, 32003
- Recruiting
Jacksonville Ctr For Clin Res
Jacksonville, Florida, 32216
- Recruiting
Monroe Biomedical Research, LLC
Monroe, North Carolina, 28112
- Not yet recruiting
Coastal Carolina Research Ctr
North Charleston, South Carolina, 29405
- Recruiting
Center for Diab,Obes & Metab
Pembroke Pines, Florida, 33024
- Not yet recruiting
PHC Accelacare
Statesville, North Carolina, 28625
- Recruiting
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598
- Recruiting
Encore Medical Research of Weston
Weston, Florida, 33331
- Recruiting
Accellacare
Wilmington, North Carolina, 28401
About this study
Official title: Tolerability of Cagrilintide in People With Obesity That Discontinued GLP-1-RA Therapies Due to Gastrointestinal Adverse Events: a Double-blinded Randomised Feasibility Study
The purpose of this clinical study is to look at the safety of the medicine Cagrilintide when compared to placebo in people who do not tolerate marketed glucagon-like peptide-1 (GLP-1) therapies and who live with overweight or obesity. Participants will get either Cagrilintide (the treatment being tested) or Placebo (a treatment that has no active medicine in it). Which treatment participant will get is decided by chance. The study will last for about 8 months.
- Conditions
- Obesity, Overweight
- Being tested
- Cagrilintide, Placebo (matched to Cagrilintide)
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CagrilintideDrug
Cagrilintide will be administered subcutaneously.
Placebo (matched to Cagrilintide)Drug
Placebo matched to Cagrilintide will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Cagrilintide | Experimental | Participants will receive Cagrilintide for 26 weeks. Receives: Drug: Cagrilintide |
| Placebo | Placebo comparator | Participants will receive placebo matched to Cagrilintide for 26 weeks. Receives: Drug: Placebo (matched to Cagrilintide) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants on standard dose or higher dose (yes/no) of cagrilintide and placebo
Measured as percentage of participants.
Measured: At week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2026
- Study start29 May 2026
- Primary completion19 Nov 2027 (estimated)
- Study completion19 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 114 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
- NCT07607587
- Sponsor's protocol ID
- NN9833-8420
- Other IDs
- U1111-1325-8511
- Status last verified
- Oct 2026
- First submitted
- 19 May 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com