Overweight, Obesity, Type 2 Diabetes
Conditions
Brief summary
The purpose of this clinical study is to find out which zenagamtide dose can be switched to, from maintenance dose of semaglutide in people with overweight or obesity, with or without type 2 diabetes (T2D). All participants will get semaglutide and zenagamtide.
Interventions
DRUGSemaglutide
Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
DRUGZenagamtide
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 (subcutaneous) s.c. semaglutide for at least 4 weeks. Only for participants with T2D: * Diagnosed with type 2 diabetes before screening. * Treatment with 0-2 marketed oral glucose-lowering medications (metformin or sodium-glucose cotransporter-2 inhibitors (SGLT2i) as a single agent or in combination) according to local label. Treatment with oral glucose-lowering medications must be stable (same drug(s), stable daily doses) for at least 90 days before screening.
Exclusion criteria
* 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 semaglutide, 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. * Use of prescription medicinal products or non-prescription drugs within 14 days before screening. Exceptions are: * use of s.c. semaglutide as described in inclusion criterion 5 * glucose-lowering medication mentioned in inclusion criterion 7 (only for participants with T2D) * stable use (initiated minimum 30 days before screening) of statins, blood pressure lowering medicine, beta blockers * highly effective contraceptives * occasional use of paracetamol, ibuprofen and acetylsalicylic acid. 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: * Glycated haemoglobin (HbA1c) more than or equal to (≥) 10.5 percent (%) \[91 millimoles per mole (mmol/mol)\] at screening. * Participant with diabetic retinopathy or maculopathy who received treatment with retinal photocoagulation, vitrectomy or anti-Vascular Endothelial Growth Factor (anti-VEGF) within 180 days before screening or are expected to require treatment within 180 days after screening. Diabetic retinopathy or maculopathy must be verified by an eye examination performed within 90 days before screening. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions, except conditions associated with diabetes mellitus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of treatment emergent adverse events (TEAE) | From first administration of zenagamtide day 1 to day 57 | Measured as number of events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC: area under the zenagamtide plasma concentration-time curve | From pre-dose on day 1 to day 8 | Measured as hours-nanomoles per liter (h\*nmol/L) |
| Cmax: the maximum observed plasma concentration of zenagamtide after first dose | From pre-dose on day 1 to day 8 | Measured as nanomoles per liter (nmol/L) |
| tmax: time to maximum observed plasma concentration of zenagamtide after first dose | From pre-dose on day 1 to day 8 | Measured as hours |
Countries
United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed