Not yet recruitingNCT07815067Updated Sep 11, 2026

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

A Phase 1 interventional study of Zenagamtide injection and Zenagamtide tablet in Overweight and Obesity, sponsored by Novo Nordisk A/S. Not yet recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-11.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Phase: Phase 1
Study type: Interventional
Enrollment: 320
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Conditions studied

Overweight
Obesity

Browse trials for

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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 design

Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 320 participants (estimated)

Study arms

Experimental
Zenagamtide subcutaneous (s.c.)
Participants will receive one of the different dose levels of zenagamtide once weekly subcutaneously.
Drug: Zenagamtide injection
Experimental
Zenagamtide oral
Participants will receive oral dose of zenagamtide once daily.
Drug: Zenagamtide tablet

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.

What researchers measure

Primary outcomes

AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state
Measured as nanomoles per liter hourly (h\*nmol/L)
Time frame: From 0 (pre-dose) up to Day 196 and Day 224

Secondary outcomes

Cmax, zenagamtide, ss: maximum observed plasma concentration of zenagamtide at steady state
Measured as nanomoles per liter (nmol/L)
Time frame: 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
Measured as hours
Time frame: 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
Measured as hours
Time frame: From pre-dose on Day 224 until completion of Day 252

Study locations

1 site

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

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

No publications or documents are linked to this record.

Registry details

Key details

Study ID: NCT07815067
Lead sponsor: Novo Nordisk A/S
Responsible party: Sponsor
First posted: Sep 11, 2026
Start date: Sep 7, 2026 (estimated)
Primary completion: Jun 12, 2028 (estimated)
Completion: Jun 12, 2028 (estimated)
Last update: Sep 11, 2026

Study contacts

Novo Nordisk

Contact

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Clinical Transparency (dept. 2834)

study director · Novo Nordisk A/S

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Overweight→

Other studies from this sponsor

Novo Nordisk A/S

Start the discussion