Trial · Interventional
RecruitingPhase 1Registry dataA Research Study Investigating How Adults With Overweight or Obesity, With or Without Type 2 Diabetes, Tolerate Switching to a New Treatment (Zenagamtide) From Their Current Tirzepatide Medication
Overview
- Status
- Recruiting
- Phase
- Phase 1
- Enrollment
- 60 participants (estimated)
- Sponsor
- Novo Nordisk A/S · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
United States
- Start
- 8 Oct 2026
- Primary completion
- 7 Sept 2028 (estimated)
- Completion
- 7 Sept 2028 (estimated)
- First posted
- 9 Oct 2026
- Last update posted
- 16 Oct 2026
- Conditions
- Overweight · Obesity · Type 2 Diabetes
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
A Research Study Investigating How Adults With Overweight or Obesity, With or Without Type 2 Diabetes, Tolerate Switching to a New Treatment (Zenagamtide) From Their Current Tirzepatide Medication
NCT078683548 Oct 2026 to est. 7 Sept 2028
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of tirzepatide in people with overweight or obesity, with or without type 2 diabetes (T2D). All participants will get tirzepatide and zenagamtide.
Interventions
- TirzepatideDrug
- ZenagamtideDrug
Arms1
Experimental
Tirzepatide and Zenagamtide
Participants will receive one of the different dose levels of tirzepatide administered once weekly by subcutaneous injection. Following the last maintenance dose of tirzepatide, participants will switch to one of the different dose levels of zenagamtide administered once weekly by subcutaneous injection.
Primary outcomes1
Outcomes the sponsor listed as primary.
Number of treatment emergent adverse events (TEAE)
Time frame · From first administration of zenagamtide day 1 to day 57
Registry description
Measured as number of events
Secondary outcomes(3)
AUC: area under the zenagamtide plasma concentration-time curve
Time frame · From pre-dose on day 1 to day 8
Registry description
Measured as hours-nanomoles per liter (h\*nmol/L)
Cmax: the maximum observed plasma concentration of zenagamtide after first dose
Time frame · From pre-dose on day 1 to day 8
Registry description
Measured as nanomoles per liter (nmol/L)
tmax: time to maximum observed plasma concentration of zenagamtide after first dose
Time frame · From pre-dose on day 1 to day 8
Registry description
Measured as hours
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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