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Trial · Interventional

RecruitingPhase 1Registry data

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

NCTNCT07868354 (opens ClinicalTrials.gov in a new tab)Other idNN9490-8554Other idU1111-1330-4403

Overview

Status
Recruiting
Phase
Phase 1
Enrollment
60 participants (estimated)
Sponsor
Novo Nordisk A/S · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
8 Oct 2026
Primary completion
7 Sept 2028 (estimated)
Completion
7 Sept 2028 (estimated)
First posted
9 Oct 2026
Last update posted
16 Oct 2026
Conditions
Overweight · Obesity · Type 2 Diabetes

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2026202720282029
  1. Ph 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 Tirzepatide Medication

    NCT07868354

    8 Oct 2026 to est. 7 Sept 2028

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • TirzepatideDrug
  • ZenagamtideDrug

Arms1

  • Experimental

    Tirzepatide and Zenagamtide

    Participants will receive one of the different dose levels of tirzepatide administered once weekly by subcutaneous injection. Following the last maintenance dose of tirzepatide, participants will switch to one of the different dose levels of zenagamtide administered once weekly by subcutaneous injection.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of treatment emergent adverse events (TEAE)

    Time frame · From first administration of zenagamtide day 1 to day 57

    Registry description

    Measured as number of events

Secondary outcomes(3)
  1. AUC: area under the zenagamtide plasma concentration-time curve

    Time frame · From pre-dose on day 1 to day 8

    Registry description

    Measured as hours-nanomoles per liter (h\*nmol/L)

  2. Cmax: the maximum observed plasma concentration of zenagamtide after first dose

    Time frame · From pre-dose on day 1 to day 8

    Registry description

    Measured as nanomoles per liter (nmol/L)

  3. tmax: time to maximum observed plasma concentration of zenagamtide after first dose

    Time frame · From pre-dose on day 1 to day 8

    Registry description

    Measured as hours

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

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