Obesity / Overweight / Zenagamtide injection · Phase 1 Trial

A Research Study Looking at the Effect of Timing of Meal After Dosing and Water Volume at Dosing on How the Medicine Zenagamtide is Taken up by the Body of Participants With Overweight or Obesity

ClinicalTrials.gov · September 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 registry record for a planned study of zenagamtide bioavailability under different meal and water conditions in individuals with overweight or obesity. No results are posted in this registry record, so no efficacy, safety, or absorption data are available for review.

What was studied

Phase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose. Overweight, Obesity; age from 18 Years. Intervention: Zenagamtide subcutaneous (s.c.); Zenagamtide oral. n = 320. 1 site: Germany.

Key findings

Safety

This is a registry record with no results posted; no efficacy, safety, or pharmacokinetic findings are available.

Who this may help

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

Plain-language summary

Phase 1 registry record with no results posted; describes a planned bioavailability study designed to measure food and water effects on zenagamtide absorption in an estimated 320 participants with overweight or obesity.

Study design

As stated by the source record.

MethodsPrimary outcome measure: AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state (assessed at From 0 (pre-dose) up to Day 196 and Day 224)

DesignPhase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationOverweight, Obesity; age from 18 Years

Sample size320

InterventionZenagamtide subcutaneous (s.c.); Zenagamtide oral

Setting1 site: Germany

Reported figures

Quoted from the source exactly as published.

Planned enrollment320

Primary outcome measureAUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state, from 0 (pre-dose) up to Day 196 and Day 224

Study phasePhase 1

Caveats

This is a registry record with no results posted; no efficacy, safety, or pharmacokinetic findings are available.
Recruitment status listed as NOT_YET_RECRUITING; study conduct, completion date, and actual enrollment remain unknown.
Study design details including randomisation method, blinding, and allocation concealment are not described in this registry record.
Primary outcome is a bioavailability surrogate; clinical significance for obesity treatment cannot be assessed from this record.

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 planned systematic variation of meal and water conditions.

Directness

moderate

Bioavailability (AUC) is a pharmacokinetic surrogate, not a clinical outcome.

Consistency

insufficient

No results reported; cannot assess consistency with other evidence.

Risk of bias

insufficient

Registry record does not describe blinding, randomisation sequence, or allocation concealment.

Sample adequacy

moderate

Estimated 320 participants planned; actual enrollment and completion unknown.

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 (NCT07815067). This is a study registration, not published results. Lead sponsor: Novo Nordisk A/S. Recruitment status: NOT_YET_RECRUITING. Phase: PHASE1. Study type: INTERVENTIONAL. Enrollment: 320 participants (ESTIMATED). Conditions: Overweight, Obesity. Interventions: DRUG: Zenagamtide injection; DRUG: Zenagamtide tablet. Primary outcome measures: AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state , From 0 (pre-dose) up to Day 196 and Day 224. Brief summary: The purpose of this clinical study is to test how taking zenagamtide tablets with different meal/water variations affects how much zenagamtide enters the bloodstream in people who have overweight or obesity. All participants will get zenagamtide.

Follow from this

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

ObesityOverweightNovo NordiskZenagamtide injectionNCT07815067Zenagamtide tablet