How a new drug (NNC0487-0111) changes energy use after weight loss in adults who are overweight or have 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 early-phase, interventional trial compares the effects of NNC0487-0111 on resting energy expenditure after weight loss in adults with overweight or obesity. Participants are assigned to receive the drug, a placebo, or a low-calorie diet and will have energy expenditure measured to see how their bodies burn calories post-weight loss. The study aims to understand if the drug alters metabolic rate differently than standard diet weight loss or no active treatment. Safety and tolerability will be monitored, and inclusion/exclusion criteria ensure participants can safely participate. The trial is conducted at multiple centers in Denmark and the Netherlands under Novo Nordisk sponsorship.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female (sex assigned at birth, inclusive of all gender identities).
* Age 18 years or older at the time of signing the informed consent.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
* Exposure to an investigational medicinal product within 30 days.
* Any condition, or disorder, which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
* Anticipated change in lifestyle (e.g., eating, exercise or sleeping pattern) during the study, for example, an imminent job change to/from a physically demanding occupation.
* Claustrophobia or severe discomfort of being confined in small rooms.
* History of type 1 or type 2 diabetes mellitus.
* Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal (GI), or endocrinological conditions.
* Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.
* 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.
* Use of incretin or amylin-based therapies prior to screening or previous discontinuation of long-term incretin and/or amylin-based therapy due to tolerability issue.
* Physical activity of moderate to vigorous intensity for greater than (\>) 4 hours/week within the past 6 months before screening.

Where it's running

• Aarhus Universitetshospital, Steno Diabetes Center Aarhus
  Aarhus N, Denmark Recruiting
• Maastricht University-NUTRIM-Dep Human Biology-Obesity
  Maastricht, Netherlands Recruiting

Study contacts

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

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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.