NNC0487-0111 / Obesity / Overweight · Phase 1 Trial

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

ClinicalTrials.gov · August 11, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a Phase 1 clinical trial registration comparing the investigational drug NNC0487-0111 to placebo and low-calorie diet on sleeping metabolic rate after weight loss in adults with obesity. No results are reported in this registry record; outcomes remain pending.

What was studied

Phase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Overweight, Obesity; age from 18 Years. Intervention: NNC0487-0111; Low Energy Diet (LED). Compared with: Placebo — Placebo Comparator. n = 120. 2 sites: Denmark, Netherlands.

Key findings

Safety

Phase 1 designation limits generalizability; efficacy and safety conclusions cannot be drawn.

Who this may help

Results from this Phase 1 trial are not yet available. Clinicians should await peer-reviewed outcome publication before considering implications for metabolic management in obesity.

Plain-language summary

Phase 1 registry record with no reported results; describes planned enrollment and primary endpoints only, requiring confirmation from future outcome data.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in sleeping metabolic rate (SMR) (assessed at Baseline (week 0) to week 12-26)

DesignPhase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose

PopulationOverweight, Obesity; age from 18 Years

Sample size120

InterventionNNC0487-0111; Low Energy Diet (LED)

ComparatorPlacebo — Placebo Comparator

Setting2 sites: Denmark, Netherlands

Reported figures

Quoted from the source exactly as published.

Planned sample size120

PhasePhase 1

Primary outcome measureChange in sleeping metabolic rate (SMR), Baseline (week 0) to week 12-26

Clinical bottom line

Results from this Phase 1 trial are not yet available. Clinicians should await peer-reviewed outcome publication before considering implications for metabolic management in obesity.

Caveats

This is a registry record with no reported results; all data are planned, not observed.
Phase 1 designation limits generalizability; efficacy and safety conclusions cannot be drawn.
No effect sizes, p-values, confidence intervals, or comparative outcomes are reported.
Randomization, blinding, and allocation concealment methods are not described in the registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Phase 1 interventional design with three arms; early-phase classification limits inference strength.

Directness

moderate

Primary outcome is sleeping metabolic rate, a physiological measure relevant to energy expenditure.

Consistency

insufficient

Registry record contains no results; consistency cannot be assessed.

Risk of bias

insufficient

Study design details (blinding, randomization) not described in registry record.

Sample adequacy

limited

Estimated enrollment 120 participants; Phase 1 designation suggests exploratory sample size.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07757087). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: Overweight, Obesity. Interventions: DRUG: NNC0487-0111; DRUG: Placebo; BEHAVIORAL: LED. Primary outcome measures: Change in sleeping metabolic rate (SMR) , Baseline (week 0) to week 12-26. 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NNC0487-0111ObesityNCT07757087OverweightNovo NordiskLED