A Phase 1 interventional study of Tirzepatide and Zenagamtide in Overweight, Obesity and Type 2 Diabetes, sponsored by Novo Nordisk A/S. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.
This study's planned enrollment of 60 is below the median of 73 across 3,263 interventional studies indexed under Overweight.
Browse Overweight studies →Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.
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Only for participants with T2D:
Exclusion Criteria:
Only for participants without T2D:
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
Only for participants with T2D:
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.
Drug: Tirzepatide · Drug: Zenagamtide
Tirzeptide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Number of treatment emergent adverse events (TEAE)
Measured as number of events
Time frame: From first administration of zenagamtide day 1 to day 57
AUC: area under the zenagamtide plasma concentration-time curve
Measured as hours-nanomoles per liter (h\*nmol/L)
Time frame: From pre-dose on day 1 to day 8
Cmax: the maximum observed plasma concentration of zenagamtide after first dose
Measured as nanomoles per liter (nmol/L)
Time frame: From pre-dose on day 1 to day 8
tmax: time to maximum observed plasma concentration of zenagamtide after first dose
Measured as hours
Time frame: From pre-dose on day 1 to day 8
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drugs tested here: Tirzepatide · Zenagamtide