How cagrilintide affects appetite and food intake in adults with overweight or obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 interventional trial evaluates the effects of cagrilintide on food intake and appetite in adults aged 18 to 64 with BMI ≥27. Participants are randomized to receive either cagrilintide or a placebo for up to 30 weeks. The study uses a controlled design to compare changes in eating behavior and appetite between groups, with safety and tolerability monitored throughout. It is conducted at Parexel International GmbH in Berlin under Novo Nordisk as the lead sponsor, with no collaborators listed. Eligible participants are generally healthy aside from overweight/obesity and meet predefined inclusion and exclusion criteria.

Why it matters

Who can join: the full rules

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.

Where it's running

• Parexel International GmbH
  Berlin, Germany Recruiting

Study contacts

• Study coordinator: Novo Nordisk
• Email: clinicaltrials@novonordisk.com
• Phone: (+1) 866-867-7178

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Berobenatide for knee pain in adults who are overweight or with obesity

  This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.

  Recruiting at 7 sites Phase 3 Pfizer · Tempe, Arizona and 39 other locations · NCT07919678

• Maridebart cafraglutide in people who switched from weekly GLP-1 receptor agonists

  This study tests how much maridebart cafraglutide appears in the blood after people with overweight or obesity switch from weekly GLP-1 receptor agonists.

  Recruiting at 9 sites Phase 1 Amgen · Phoenix, Arizona and 8 other locations · NCT07908316

• EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

  This trial tests whether a coformulation of eloralintide and tirzepatide helps people with obesity or overweight and type 2 diabetes lose weight compared with tirzepatide alone.

  Recruiting Phase 3 Eli Lilly and Company · Tucson, Arizona and 74 other locations · NCT07881458

• Monthly dose of PF-08653944 vs placebo in Chinese adults who are overweight or obese

  This study tests whether berobenatide (PF-08653944) given once a month helps adults in China lose weight compared with a placebo.

  Recruiting Phase 3 Pfizer · Hefei, Anhui and 5 other locations · NCT07874633

• FutureShape Family: a family-based weight-management program with semaglutide for children and parents

  This trial tests whether a family-centered program that combines a prescription medication (semaglutide) with lifestyle support and app-based coaching can help adults with obesity and their children who are overweight/obese.

  Recruiting Phase 4 University of Copenhagen · Copenhagen · NCT07872904

• Home self-administration of a weight-management medicine with an autoinjector in adults who are overweight or obese

  This study tests whether adults who are overweight or have obesity can successfully self-administer maridebart cafraglutide at home using an autoinjector.

  Recruiting at 25 sites Phase 3 Amgen · San Diego, California and 24 other locations · NCT07871409

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.