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Trial · Interventional

RecruitingPhase 1Registry data

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

NCTNCT07757087 (opens ClinicalTrials.gov in a new tab)Other idNN9490-8152Other idU1111-1324-2934Other id2025-522744-40Other id2025

Overview

Status
Recruiting
Phase
Phase 1
Enrollment
120 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

Denmark, Netherlands

Start
3 Aug 2026
Primary completion
18 Sept 2028 (estimated)
Completion
18 Sept 2028 (estimated)
First posted
11 Aug 2026
Last update posted
1 Oct 2026
Conditions
Overweight · Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 1

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

    NCT07757087

    3 Aug 2026 to est. 18 Sept 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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 or overweight 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).

Interventions

  • NNC0487-0111Drug
  • PlaceboDrug
  • LEDBehavioral

Arms3

  • Experimental

    NNC0487-0111

    Participants will receive once weekly subcutaneous injection of NNC0487-0111.

  • Placebo comparator

    Placebo

    Participants will receive once weekly subcutaneous injection of placebo matched to NNC0487-0111.

  • Other

    Low Energy Diet (LED)

    Participants will receive a low-energy dietary designed to achieve a reduction in body weight.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in sleeping metabolic rate (SMR)

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

    Registry description

    Measured in kilojoules per day (kJ/day)

Secondary outcomes(4)
  1. Change in 24-hour energy expenditure (EE)

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

    Registry description

    Measured in kJ/day.

  2. Change in basal metabolic rate (BMR)

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

    Registry description

    Measured in kJ/day.

  3. Change in resting metabolic rate (RMR)

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

    Registry description

    Measured in kJ/day.

  4. Change in diet-induced thermogenesis (DIT)

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

    Registry description

    Measured in kJ/day.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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