What this study is
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.
What's being tested
- Semaglutide
Intervention · DRUG
Semaglutide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
- Zenagamtide
Intervention · DRUG
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
Study details
- Official title
- An Open-label, Multiple-arm Study to Assess Tolerability in Participants With Overweight or Obesity, With or Without Type 2 Diabetes, When Switching From Semaglutide to Zenagamtide
- Sponsor
- Novo Nordisk A/S
- Conditions
- Overweight · Obesity · Type 2 Diabetes
- Enrolling
- 60 people
- Starts
- 2026-10-05
- Est. completion
- 2028-09-06
- Design
- Open-label, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedAll participants
You may qualify if
- 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.
You can't join if
- 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 with T2D
You may qualify if
- 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.
You can't join if
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (2)
2 openPAREXEL Glendale/LA EPCU
Glendale, California, United States
RecruitingPAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland, United States
Recruiting
Study team
Sponsor
Novo Nordisk A/S
Study ID NN9490-8553
Study director
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.