OverweightPhase 1NCT07868354
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
A Phase 1 study testing Tirzepatide and Zenagamtide in people with Overweight and Obesity, run by Novo Nordisk A/S at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight, Obesity, Type 2 Diabetes
- What is being tested?
- Tirzepatide and Zenagamtide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Oct 2026to 7 Sep 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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.
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
PAREXEL Intl - EPCU-Baltimore
Baltimore, Maryland, 21225
- Recruiting
PAREXEL Glendale/LA EPCU
Glendale, California, 91206
About this study
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 Tirzepatide to Zenagamtide
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.
- Conditions
- Overweight, Obesity, Type 2 Diabetes
- Being tested
- Tirzepatide, Zenagamtide
- Medical subject headings
- Overweight, Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Tirzeptide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
ZenagamtideDrug
Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide and Zenagamtide | Experimental | 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. Receives: Drug: Tirzepatide; Drug: Zenagamtide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of treatment emergent adverse events (TEAE)
Measured as number of events
Measured: From first administration of zenagamtide day 1 to day 57
Secondary outcomes (3)
AUC: area under the zenagamtide plasma concentration-time curve
Measured as hours-nanomoles per liter (h*nmol/L)
Measured: From pre-dose on day 1 to day 8
Cmax: the maximum observed plasma concentration of zenagamtide after first dose
Measured as nanomoles per liter (nmol/L)
Measured: From pre-dose on day 1 to day 8
tmax: time to maximum observed plasma concentration of zenagamtide after first dose
Measured as hours
Measured: From pre-dose on day 1 to day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2026
- Study start8 Oct 2026
- Primary completion7 Sep 2028 (estimated)
- Study completion7 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Transparency (dept. 2834), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07868354
- Sponsor's protocol ID
- NN9490-8554
- Other IDs
- U1111-1330-4403
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com