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Trial · Interventional

RecruitingPhase 1Registry data

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

NCTNCT07815067 (opens ClinicalTrials.gov in a new tab)Other idNN9487-8155Other idU1111-1316-5947Other id2025-521383-35Other id2025
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Recruiting
Phase
Phase 1
Enrollment
320 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Germany

Start
7 Sept 2026
Primary completion
12 Jun 2028 (estimated)
Completion
12 Jun 2028 (estimated)
First posted
11 Sept 2026
Last update posted
7 Oct 2026
Conditions
Overweight · Obesity

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 1

    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

    NCT07815067

    7 Sept 2026 to est. 12 Jun 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Zenagamtide injectionDrug
  • Zenagamtide tabletDrug

Arms2

  • Experimental

    Zenagamtide subcutaneous (s.c.)

    Participants will receive one of the different dose levels of zenagamtide once weekly subcutaneously.

  • Experimental

    Zenagamtide oral

    Participants will receive oral dose of zenagamtide once daily.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state

    Time frame · From 0 (pre-dose) up to Day 196 and Day 224

    Registry description

    Measured as nanomoles per liter hourly (h\*nmol/L)

Secondary outcomes(3)

  1. Cmax, zenagamtide, ss: maximum observed plasma concentration of zenagamtide at steady state

    Time frame · From Day 196 to Day 197 and from Day 224 to Day 225

    Registry description

    Measured as nanomoles per liter (nmol/L)

  2. tmax, zenagamtide, ss: the time to maximum observed plasma concentration of zenagamtide at steady state

    Time frame · From Day 196 to Day 197 and from Day 224 to Day 225

    Registry description

    Measured as hours

  3. t1/2, ss; the terminal half-life of zenagamtide after the last dose

    Time frame · From pre-dose on Day 224 until completion of Day 252

    Registry description

    Measured as hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female (sex assigned at birth, inclusive of all gender identities). * Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator. Exclusion Criteria: * Known or suspected hypersensitivity to study intervention(s) or related products. * Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Presence of clinically significant gastrointestinal disorders or symptoms of gastrointestinal disorders potentially affecting absorption of drugs or nutrients, or as judged by the investigator. * Unusual meal habits (including, but not limited to, eating disorders) and special diet * HbA1c more than or equal to (≥) 6.5 percent (%) \[48 (nanomoles per mole) mmol/mol\] at screening.

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