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

September 6, 2026 updated by: Novo Nordisk A/S

Investigating the Effect of Post-dose Meal Timings and Water Volume at Dosing on the Pharmacokinetic Properties of Oral Zenagamtide in Participants With Overweight or Obesity

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

320

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zenagamtide subcutaneous (s.c.)
Participants will receive one of the different dose levels of zenagamtide once weekly subcutaneously.
Drug: Zenagamtide injection
Zenagamtide will be administered to one of the body parts: thigh, abdomen or upper arm
Experimental: Zenagamtide oral
Participants will receive oral dose of zenagamtide once daily.
Drug: Zenagamtide tablet
Zenagamtide tablet will be taken in the morning in fasted state.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured as nanomoles per liter hourly (h*nmol/L)
From 0 (pre-dose) up to Day 196 and Day 224

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured as nanomoles per liter (nmol/L)
From Day 196 to Day 197 and from Day 224 to Day 225
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
Measured as hours
From Day 196 to Day 197 and from Day 224 to Day 225
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
Measured as hours
From pre-dose on Day 224 until completion of Day 252

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 7, 2026

Primary Completion (Estimated)

June 12, 2028

Study Completion (Estimated)

June 12, 2028

Study Registration Dates

First Submitted

September 6, 2026

First Submitted That Met QC Criteria

September 6, 2026

First Posted (Actual)

September 11, 2026

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 6, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9487-8155
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • U1111-1316-5947 (Other Identifier: World Health Organization (WHO))
  • 2025-521383-35 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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