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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
Plain-language guide to NCT07868354: phase 1 interventional trial of Tirzepatide, 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07868354
- Phase
- phase 1
- Status
- recruiting participants
- Start
- 2026-10-08
- Completion (planned or actual)
- 2028-09-07
- Participants
- 60 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Overweight; Obesity; Type 2 Diabetes
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Tirzepatide.
All participants will get tirzepatide and zenagamtide.
It had 1 arm (groups): Tirzepatide and Zenagamtide (experimental).
The registry classes the interventions as drug.
Who Took Part
60 planned participants were the target.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: 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. Diagnosed with type 2 diabetes before screening.
The full record lists 6 inclusion and 13 exclusion criteria; among the exclusions: female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method; 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.
How the Study Was Run
It was run as a sequential and open-label study.
Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.
It started in 2026-10-08 with completion listed for 2028-09-07.
It ran at 2 sites in United States (2).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of treatment emergent adverse events (TEAE) (time frame: From first administration of zenagamtide day 1 to day 57).
It also tracked 3 secondary outcomes, for example AUC: area under the zenagamtide plasma concentration-time curve.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Tirzepatide in 60 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Tirzepatide compound page, all human trials.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.