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

NCT07757087 | Recruiting Phase 1

• 3 other identifiers: NN9490-8152U1111-1324-29342025-522744-40
• Study Type: interventional
• Target: 120
• Locations: 2 countries
• Sites: 2

Brief Summary

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).

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Change in sleeping metabolic rate (SMR)

  Measured in kilojoules per day (kJ/day)

  Baseline (week 0) to week 12-26

Secondary Outcomes (4)

• Change in 24-hour energy expenditure (EE)

  Baseline (week 0) to week 12-26

• Change in basal metabolic rate (BMR)

  Baseline (week 0) to week 12-26

• Change in resting metabolic rate (RMR)

  Baseline (week 0) to week 12-26

• Change in diet-induced thermogenesis (DIT)

  Baseline (week 0) to week 12-26

Study Arms (3)

NNC0487-0111

EXPERIMENTAL

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

Drug: NNC0487-0111

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Low Energy Diet (LED)

OTHER

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

Behavioral: LED

Interventions

NNC0487-0111 DRUG

NNC0487-0111 will be administered subcutaneously.

NNC0487-0111

Placebo DRUG

Placebo matched to NNC0487-0111 will be administered subcutaneously.

Placebo

LED BEHAVIORAL

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

Low Energy Diet (LED)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

RECRUITING

Maastricht University-NUTRIM-Dep Human Biology-Obesity

Maastricht, 6211 LK, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 11, 2026
• Study Start: August 3, 2026
• Primary Completion (Estimated): September 18, 2028
• Study Completion (Estimated): September 18, 2028
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

NL (1); DK (1)