OverweightPhase 1NCT07815067
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 study testing Zenagamtide injection and Zenagamtide tablet in people with Overweight and Obesity, run by Novo Nordisk A/S at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity
- What is being tested?
- Zenagamtide injection and Zenagamtide tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteGermany
- Study dates
- 7 Sep 2026to 12 Jun 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Charité - Campus Charité Mitte - Charité Research Organisation GmbH
Berlin, 10117
About this study
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
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
- Being tested
- Zenagamtide injection, Zenagamtide tablet
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zenagamtide injectionDrug
Zenagamtide will be administered to one of the body parts: thigh, abdomen or upper arm
Zenagamtide tabletDrug
Zenagamtide tablet will be taken in the morning in fasted state.
| Study group | Role | What they receive |
|---|---|---|
| Zenagamtide subcutaneous (s.c.) | Experimental | Participants will receive one of the different dose levels of zenagamtide once weekly subcutaneously. Receives: Drug: Zenagamtide injection |
| Zenagamtide oral | Experimental | Participants will receive oral dose of zenagamtide once daily. Receives: Drug: Zenagamtide tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured as nanomoles per liter (nmol/L)
Measured: 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
Measured: 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
Measured: From pre-dose on Day 224 until completion of Day 252
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start7 Sep 2026
- Primary completion12 Jun 2028 (estimated)
- Study completion12 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07815067
- Sponsor's protocol ID
- NN9487-8155
- Other IDs
- U1111-1316-5947, 2025-521383-35, 2025
- Status last verified
- Oct 2026
- First submitted
- 6 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com