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.
Male or female (sex assigned at birth, inclusive of all gender identities).
Age 18 years or older at the time of signing the informed consent.
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.
Participants on a stable treatment dose of tirzepatide for at least 4 weeks.
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
History of reduction in dose of tirzepatide, due to intolerability, without successful reescalation.
Presence of any clinically relevant condition that causes symptoms which are similar to the gastrointestinal adverse events (GI AEs) linked to glucagon-like peptide-1 receptor agonist (GLP-1 RA) treatment, and which could confound evaluation of GLP-1 RA-related GI AEs and tolerability endpoints.
Ongoing use of medications causing clinically relevant gastrointestinal symptoms that could confound evaluation of GLP-1 RA-related GI AEs and tolerability endpoints, as judged by the investigator.
Sequential
Tirzepatide
DrugTirzeptide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Zenagamtide
DrugZenagamtide 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
AUC: area under the zenagamtide plasma concentration-time curve
Measured as hours-nanomoles per liter (h\*nmol/L)
Cmax: the maximum observed plasma concentration of zenagamtide after first dose
Measured as nanomoles per liter (nmol/L)
tmax: time to maximum observed plasma concentration of zenagamtide after first dose
Measured as hours
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