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
- 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.
- Short title
- 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
- Official 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2028-06-12
- First posted
- 2026-09-11
- Registry last updated
- 2026-10-07
- Primary completion date
- 2028-06-12
- Start date
- 2026-09-07
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Novo Nordisk A/S
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07815067
- ClinicalTrials.gov ID
- NCT07815067
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
AUC, zenagamtide, steady state (ss): area under the zenagamtide plasma concentration-time curve during a dosing interval at steady state
Timeframe: From 0 (pre-dose) up to Day 196 and Day 224
Measured as nanomoles per liter hourly (h\*nmol/L)
Cmax, zenagamtide, ss: maximum observed plasma concentration of zenagamtide at steady state
Timeframe: 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
Timeframe: 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
Timeframe: From pre-dose on Day 224 until completion of Day 252
Measured as hours
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
- 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.
- 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.
- Charité - Campus Charité Mitte - Charité Research Organisation GmbHBerlin, GermanyRecruiting
- 2025
- 2025-521383-35
- U1111-1316-5947