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 | Recruiting Phase 1

• 4 other identifiers: NN9487-8155U1111-1316-59472025-521383-352025
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• 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)

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

Secondary Outcomes (3)

• 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

• 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

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

  From pre-dose on Day 224 until completion of Day 252

Study Arms (2)

Zenagamtide subcutaneous (s.c.)

EXPERIMENTAL

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

Drug: Zenagamtide injection

Zenagamtide oral

EXPERIMENTAL

Participants will receive oral dose of zenagamtide once daily.

Drug: Zenagamtide tablet

Interventions

Zenagamtide injection DRUG

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

Zenagamtide subcutaneous (s.c.)

Zenagamtide tablet DRUG

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

Zenagamtide oral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2026
• First Posted: September 11, 2026
• Study Start: September 7, 2026
• Primary Completion (Estimated): June 12, 2028
• Study Completion (Estimated): June 12, 2028
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)