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

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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07815067

Enrollment

320

Registered

2026-09-11

Start date

2026-09-07

Completion date

2028-06-12

Last updated

2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Overweight

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.

Interventions

DRUGZenagamtide injection

Zenagamtide will be administered to one of the body parts: thigh, abdomen or upper arm

DRUGZenagamtide tablet

Zenagamtide tablet will be taken in the morning in fasted state.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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	Measured as nanomoles per liter hourly (h\*nmol/L)

Secondary

Measure	Time frame	Description
Cmax, zenagamtide, ss: maximum observed plasma concentration of zenagamtide at steady state	From Day 196 to Day 197 and from Day 224 to Day 225	Measured as nanomoles per liter (nmol/L)
tmax, zenagamtide, ss: the time to maximum observed plasma concentration of zenagamtide at steady state	From Day 196 to Day 197 and from Day 224 to Day 225	Measured as hours
t1/2, ss; the terminal half-life of zenagamtide after the last dose	From pre-dose on Day 224 until completion of Day 252	Measured as hours

Countries

Germany

Contacts

CONTACTNovo Nordisk

clinicaltrials@novonordisk.com(+1) 866-867-7178

STUDY_DIRECTORClinical Transparency (dept. 2834)

Novo Nordisk A/S

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026