RecruitingPhase 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 Semaglutide Medication

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests which dose of zenagamtide adults can switch to from a steady dose of semaglutide, and how well they tolerate the switch. It is for adults with overweight or obesity, with or without type 2 diabetes. Everyone in the study will get semaglutide and zenagamtide.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older. All sexes and gender identities may join.
  • The study doctor must find you eligible based on your health history, exam, vital signs, heart tracing, and lab tests.
  • Have used the same dose of semaglutide injected under the skin for at least 4 weeks.
  • If you have type 2 diabetes, it must have been diagnosed before screening.
  • If you have type 2 diabetes, take no more than 2 approved diabetes pills: metformin, an SGLT2 inhibitor, or both. These lower blood sugar. Any such treatment must stay the same for at least 90 days before screening.

Who can't join

  • You are pregnant, breastfeeding, planning pregnancy, or able to become pregnant but not using adequate birth control.
  • You lowered your semaglutide dose because of side effects and could not successfully raise it again.
  • You have a health problem that causes stomach or bowel symptoms similar to this type of treatment’s side effects, making those side effects hard to judge.
  • You take medicines that cause stomach or bowel symptoms that could make the study results hard to judge.
  • You used prescription or over-the-counter drugs within 14 days before screening. Exceptions include the allowed semaglutide and diabetes medicines; statins, blood pressure medicines, or beta blockers started at least 30 days earlier; highly effective birth control; and occasional paracetamol, ibuprofen, or aspirin.
  • You have or have had significant lung, metabolism, kidney, liver, heart, blood vessel, stomach, bowel, or hormone problems. For people with type 2 diabetes, conditions linked to diabetes are allowed.
  • If you have type 2 diabetes, your HbA1c, a measure of average blood sugar, is 10.5% or higher at screening.
  • If you have type 2 diabetes, you had laser treatment, surgery, or anti-VEGF medicine for diabetes-related eye damage within 180 days before screening, or expect to need it within 180 days after screening. An eye exam within 90 days before screening must check for this damage. Eye-dilating drops are required unless a special camera is used.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (2)

CA

MD