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NCT Number: NCT07815067

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zenagamtide injection

Drug

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

Zenagamtide tablet

Drug

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

Primary outcomes

  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

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

Secondary outcomes

  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

    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

    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

    Measured as hours

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 11, 2026
Registry last updated
Sep 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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