RecruitingPhase 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

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

Lead sponsor

Novo Nordisk A/S

Asset

Amycretin / zenagamtide

Subcutaneous · GLP-1 / amylin

Listed sites

Recruiting sites

Estimated enrollment

120

Study population

Obesity / overweight

Eligibility highlights

Primary endpoint

•Sleeping metabolic rate (SMR)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07757087

Org study IDNN9490-8152

Secondary ID2025

Secondary ID2025-522744-40European Medical Agency (EMA)

Secondary IDU1111-1324-2934World Health Organization (WHO)

Timeline

Milestones

Study start2026-08-03actual

Study first posted2026-08-11actual

Last update posted2026-10-01actual

Primary completion2028-09-18estimated

Study completion2028-09-18estimated

Assets

Investigational agents

Amycretin / zenagamtide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Other (unclassified)

5 endpoints

Primary/protocol endpoint/low confidence

Change in sleeping metabolic rate (SMR)

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