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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 Tirzepatide 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 Tirzepatide 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 zenagamtide dose people can switch to from a steady dose of tirzepatide and how well they tolerate it. It is for adults with overweight or obesity, with or without type 2 diabetes. Everyone will get both medicines during the study.

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.

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

Eligibility

Who can join

  • Age 18 or older. All gender identities are welcome.
  • The study doctor finds you eligible based on your health history, exam, heart tracing, and other screening tests.
  • You have taken a steady dose of tirzepatide for at least 4 weeks.
  • If you have type 2 diabetes, you were diagnosed before screening.
  • If you have type 2 diabetes, you take no more than 2 allowed blood sugar pills: metformin, an SGLT2 inhibitor, or both. If used, these medicines and their daily doses must have stayed the same for at least 90 days before screening.

Who can't join

  • You are pregnant, breastfeeding, planning to become pregnant, or able to become pregnant but not using adequate birth control.
  • You lowered your tirzepatide dose because of side effects and could not successfully raise it again.
  • You have a health condition or take medicines that cause stomach or bowel symptoms that could make the study's side effects hard to judge.
  • You used prescription or over-the-counter drugs within 14 days before screening, except allowed medicines. These include the study's allowed tirzepatide and diabetes medicines; cholesterol-lowering statins, blood pressure medicines, or beta blockers started at least 30 days before screening; highly effective birth control; and occasional acetaminophen, ibuprofen, or aspirin.
  • You have or have had a significant lung, kidney, liver, heart, blood vessel, stomach, bowel, hormone, or metabolism condition. Metabolism is how your body uses food for energy. For people with type 2 diabetes, diabetes-related conditions are excepted from this rule.
  • If you have type 2 diabetes, your HbA1c is 10.5% or higher at screening. This blood test measures average blood sugar over time.
  • If you have type 2 diabetes, you had certain treatments for diabetes-related eye damage within 180 days before screening, or expect to need them within 180 days afterward. These include retinal laser treatment, surgery to remove gel inside the eye, or anti-VEGF medicine to block blood vessel growth. An eye exam within 90 days before screening must check for this damage; pupil-widening drops are needed 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 tirzepatide 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 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. * Use of prescription medicinal products or non-prescription drugs within 14 days before screening. Exceptions are: * use of tirzepatide 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