Obesity / NNC6022-0004 / Elevated High Sensitivity C Reactive Protein (hscrp) · Phase 1 Trial

A Study to See How Safe a New Medicine (NNC6022-0004) is in Healthy People and People Living With Obesity

ClinicalTrials.gov · August 19, 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 NNC6022-0004, a novel agent being evaluated in healthy adults and adults with obesity. The study is currently recruiting and focuses on safety, tolerability, and pharmacokinetic characterization; no efficacy outcomes or results are yet reported in this registry record.

What was studied

Phase 1, Interventional, Randomized, Parallel, Quadruple masking, Treatment purpose. Obesity, Elevated High-sensitivity C-reactive Protein (hsCRP); age from 18 Years; to 65 Years; accepts healthy volunteers. Intervention: NNC6022-0004. Compared with: Placebo — Placebo Comparator. n = 128. 1 site: Netherlands.

Key findings

Safety

This is a study registration; no efficacy, safety, or pharmacokinetic results are reported.

Who this may help

This early-phase trial will establish the safety profile and pharmacokinetic behavior of NNC6022-0004 in target populations. Clinicians should await publication of results before interpreting any clinical relevance.

Plain-language summary

This is a Phase 1 safety and pharmacokinetic study registration with no results posted; it describes planned enrollment and primary outcome measures only.

Study design

As stated by the source record.

MethodsPrimary outcome measures: Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose (assessed at From pre-dose (Day 1) until visit 3 (Day 9)); Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose (assessed at From pre-dose (Day 1) until visit 3 (Day 9)); Part B: Number of treatment emergent adverse events (TEAE) (assessed at From time of dosing (Day 1) to end of study visit (Day 14)); Part C: Number of treatment emergent adverse events (assessed at From time of dosin…

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

PopulationObesity, Elevated High-sensitivity C-reactive Protein (hsCRP); age from 18 Years; to 65 Years; accepts healthy volunteers

Sample size128

InterventionNNC6022-0004

ComparatorPlacebo — Placebo Comparator

Setting1 site: Netherlands

Reported figures

Quoted from the source exactly as published.

Planned enrollment128

PhasePhase 1

Primary outcome Part AAUC0-tz and Cmax of NNC6022-0001 after single dose (Days 1–9)

Primary outcome Parts B, C, D, ENumber of treatment-emergent adverse events (duration varies Days 1–41)

Clinical bottom line

Caveats

This is a study registration; no efficacy, safety, or pharmacokinetic results are reported.
No outcomes are yet available; recruitment status is active.
Blinding methodology not specified in registry record.
Study is not yet complete; follow-up duration and final analysis approach not detailed beyond primary outcome timeframes.

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

Randomized, placebo-controlled Phase 1 study with multiple ascending dose cohorts planned.

Directness

limited

Primary outcomes are pharmacokinetic and safety measures, not efficacy in obesity.

Consistency

insufficient

No results reported; consistency cannot be assessed from registration alone.

Risk of bias

moderate

Randomized and placebo-controlled design; blinding status not specified in registry record.

Sample adequacy

limited

Estimated 128 participants total across multiple ascending dose parts and populations.

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 (NCT07693868). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 128 participants (ESTIMATED). Conditions: Obesity, Elevated High-sensitivity C-reactive Protein (hsCRP). Interventions: DRUG: NNC6022-0004; DRUG: Placebo. Primary outcome measures: Part A: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose , From pre-dose (Day 1) until visit 3 (Day 9); Part A: Maximum observed plasma concentration (Cmax) of NNC6022-0001 after a single dose , From pre-dose (Day 1) until visit 3 (Day 9); Part B: Number of treatment emergent adverse events (TEAE) , From time of dosing (Day 1) to end of study visit (Day 14); Part C: Number of treatment emergent adverse events , From time of dosing (Day 1) to end of study visit (Day 41); Part D: Area under the NNC6022-0001 plasma concentration-time curve from time 0 to last measurable plasma concentration (AUC0-tz) after a single dose , From pre-dose (Day 1 or Day 8) to end of visit (Day 5 or Day 12); Part E: Number of treatment emergent adverse events , From time of dosing (Day 1) to end of study visit (Day 13). Brief summary: This study is being done to look at the efficacy single and multiple ascending dose study investigating safety, tolerability, pharmacokinetics, food effect and target engagement in healthy adults including a single cohort in adults living with obesity. Participants will either get NNC6022-0004, (the treatment being tested) or Placebo (a treatment that has no active medicine in it) and 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.

ObesityNNC6022-0004Novo NordiskNCT07693868Elevated High Sensitivity C Reactive Protein (hscrp)