NNC0113-5840 / Obesity / Overweight · Phase 1 Trial

A Research Study Investigating How a New Medicine NNC0113-5840 Works in People With Overweight or Obesity

ClinicalTrials.gov · September 9, 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 for NNC0113-5840, a novel investigational drug for obesity and overweight. The study is currently recruiting and no results are yet available; the registry record documents only planned methods and safety monitoring endpoints.

What was studied

Phase 1, Interventional, Randomized, Sequential, Double masking, Treatment purpose. Obesity, Overweight; age from 18 Years; to 55 Years. Intervention: Cohort 1 NNC0113-5840; Cohort 2 NNC0113-5840; Cohort 3 NNC0113-5840; Cohort 4 NNC0113-5840; Cohort 5 NNC0113-5840; Cohort 6 NNC0113-5840. Compared with: Placebo matching NNC0113-5840 — Placebo Comparator. n = 48. 2 sites: United States.

Key findings

Safety

This is a registry record with no results posted; outcomes, effect sizes, and safety data are not yet available. Phase 1 design focuses on safety and tolerability, not efficacy or clinical benefit.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

Phase 1 safety study with no posted results; registry record describes planned conduct only, not outcomes.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Number of treatment emergent adverse events (TEAEs) (assessed at From time of dosing (day 1) up to day 43)

DesignPhase 1, Interventional, Randomized, Sequential, Double masking, Treatment purpose

PopulationObesity, Overweight; age from 18 Years; to 55 Years

Sample size48

InterventionCohort 1 NNC0113-5840; Cohort 2 NNC0113-5840; Cohort 3 NNC0113-5840; Cohort 4 NNC0113-5840; Cohort 5 NNC0113-5840; Cohort 6 NNC0113-5840

ComparatorPlacebo matching NNC0113-5840 — Placebo Comparator

Setting2 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment48

Study phasePhase 1

Primary outcome measureNumber of treatment emergent adverse events (TEAEs), from day 1 to day 43

Study designRandomized, placebo-controlled

Caveats

This is a registry record with no results posted; outcomes, effect sizes, and safety data are not yet available.
Phase 1 design focuses on safety and tolerability, not efficacy or clinical benefit.
Randomization method, blinding details, and exact dose or exposure schedule not specified in registry text.
Study is still recruiting; no analysis or participant follow-up data have been reported.

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, randomized, placebo-controlled, but early-stage safety assessment only.

Directness

limited

Primary endpoint is safety (TEAEs), not efficacy or clinical benefit.

Consistency

insufficient

Single study; no comparator data or prior published results cited.

Risk of bias

moderate

Randomization method and blinding not detailed in registry record.

Sample adequacy

limited

Estimated enrollment 48 participants; typical Phase 1 size but small for robust safety profiling.

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 (NCT07566390). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 48 participants (ESTIMATED). Conditions: Obesity, Overweight. Interventions: DRUG: NNC0113-5840; DRUG: Placebo. Primary outcome measures: Number of treatment emergent adverse events (TEAEs) , From time of dosing (day 1) up to day 43. Brief summary: The purpose of this clinical study is to find out if NNC0113-5840 is safe for treating people with excess body weight. There are 2 study treatments in this study, participants will get either NNC0113-5840 (the product being tested) or Placebo (treatment that has no active medicine in it), Which treatment participants get is decided by chance.

Follow from this

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

NNC0113-5840ObesityOverweightNovo NordiskNCT07566390