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NCT Number: NCT07757087

A Research Study to See How NNC0487-0111 Affects the Body's Energy Use After a Weight Loss in Adults Living With Obesity, Compared to a Low-calorie Diet or Placebo

The purpose of this clinical study is to evaluate how NNC0487-0111 affects the amount of energy the body uses in people living with obesity following weight loss. This will be compared with the amount of energy used by participants who achieve weight loss through a low-calorie diet and by participants receiving placebo (without weight loss).

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aarhus Universitetshospital, Steno Diabetes Center Aarhus, Aarhus N, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 before screening.
  • 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 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.

Treatment and study plan

NNC0487-0111

Drug

NNC0487-0111 will be administered subcutaneously.

Placebo

Drug

Placebo matched to NNC0487-0111 will be administered subcutaneously.

LED

Behavioral

A meal plan and meal replacements will be provided by the investigators.

Primary outcomes

  1. Change in sleeping metabolic rate (SMR)

    Time frame: Baseline (week 0) to week 12-26

    Measured in kilojoules per day (kJ/day)

Secondary outcomes

  1. Change in 24-hour energy expenditure (EE)

    Time frame: Baseline (week 0) to week 12-26

    Measured in kJ/day.

  2. Change in basal metabolic rate (BMR)

    Time frame: Baseline (week 0) to week 12-26

    Measured in kJ/day.

  3. Change in resting metabolic rate (RMR)

    Time frame: Baseline (week 0) to week 12-26

    Measured in kJ/day.

  4. Change in diet-induced thermogenesis (DIT)

    Time frame: Baseline (week 0) to week 12-26

    Measured in kJ/day.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

The Effect of Once-weekly Subcutaneous NNC0487-0111 Compared to an Energy-restricted Diet or Placebo on Energy Metabolism in Adults Living With Obesity: a Randomised, Placebo-controlled Study

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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