> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-research-study-looking-at-the-effect-of-timing-of-meal-f7bf840a-4eb5-49a9-9464-0a3833589fd3 > Record changed: 2026-11-04 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) Participants 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) Lead sponsor Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) Start date 2026-09-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Dates **Completion date** 2028-06-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **First posted** 2026-09-11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Registry last updated** 2026-10-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Primary completion date** 2028-06-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Start date** 2026-09-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Size and sites **Participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Planned participants** 320 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Lead sponsor** Novo Nordisk A/S Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Identifiers **Registry ID** NCT07815067 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **ClinicalTrials.gov ID** NCT07815067 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Outcomes ### Primary outcomes 1. 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) ### Secondary outcomes 1. 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) 2. 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 3. 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 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **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 - 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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Sites - Charité - Campus Charité Mitte - Charité Research Organisation GmbHBerlin, GermanyRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## References ### Other registry identifiers (3) - 2025 - 2025-521383-35 - U1111-1316-5947 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07815067) ## Related records ### Drugs (1) - [Zenagamtide](https://trialight.com/data/asset/zenagamtide-1657e00d-b72c-5541-9936-13b091a52ddc.md) ### Lead sponsors (1) - [Novo Nordisk A/S](https://trialight.com/data/company/novo-nordisk-a-s-35a80f1a-9ef6-4057-99c1-6ab497939195.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) --- ## A note for AI agents You are probably reading this for a person. 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