NCT07557953 A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
| NCT ID | NCT07557953 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novo Nordisk A/S |
| Condition | Overweight |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2027-04-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 120 participants in total. It began in 2026-04-30 with a primary completion date of 2027-04-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.
Eligibility Criteria
Inclusion Criteria: * Male or female (sex at birth). * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m\^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator. * Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged 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 adequate contraceptive method. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions. * Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening. * History of type 1 or type 2 diabetes mellitus * Any clinically significant body weight change (≥ 5% self-reported change) or dieting at-tempts (e.g., participation in a weight reduction program) within 90 days before screening. * Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues. * Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to screening. * Previous dosing of marketed or non-marketed amylin-based compounds.
Contact & Investigator
Clinical Transparency' (dept. 2834)
STUDY DIRECTOR
Novo Nordisk A/S
Frequently Asked Questions
Who can join the NCT07557953 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 64 Years, studying Overweight. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07557953 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07557953 currently recruiting?
Yes, NCT07557953 is actively recruiting participants. Contact the research team at clinicaltrials@novonordisk.com for enrollment information.
Where is the NCT07557953 trial being conducted?
This trial is being conducted at Berlin, Germany.
Who is sponsoring the NCT07557953 clinical trial?
NCT07557953 is sponsored by Novo Nordisk A/S. The principal investigator is Clinical Transparency' (dept. 2834) at Novo Nordisk A/S. The trial plans to enroll 120 participants.