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RecruitingNCT07868354Updated Oct 16, 2026

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 interventional study of Tirzepatide and Zenagamtide in Overweight, Obesity and Type 2 Diabetes, sponsored by Novo Nordisk A/S. Recruiting at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-16.

Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment

Updated Oct 16, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
60
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Overweight
  • Obesity
  • Type 2 Diabetes
03

In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's planned enrollment of 60 is below the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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.

    Drug: Tirzepatide · Drug: Zenagamtide

Interventions

  • Tirzeptide will be administered subcutaneously using pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

  • Zenagamtide will be administered subcutaneously using PDS290 pre-filled pen-injectors to one of the body parts: thigh, abdomen or upper arm.

06

What researchers measure

Primary outcomes

  1. Number of treatment emergent adverse events (TEAE)

    Measured as number of events

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

Secondary outcomes

  1. AUC: area under the zenagamtide plasma concentration-time curve

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

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

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

    Measured as nanomoles per liter (nmol/L)

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

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

    Measured as hours

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

07

Study locations

2 of 2 sites recruiting
  • PAREXEL Glendale/LA EPCU
    Glendale, California 91206, United States
    Recruiting
  • PAREXEL Intl - EPCU-Baltimore
    Baltimore, Maryland 21225, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Data sharing details ↗ · novonordisk-trials.com

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Oct 16, 2026
Sites
2 sites changed recruiting status
Oct 16, 2026
Registered
First appeared on the registry
Oct 9, 2026
Show all 2 updates
  1. Oct 16, 2026
    Not yet recruiting→Recruiting
    2 sites changed recruiting status
    + 1 other change: date precision
  2. Oct 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07868354
Lead sponsor
Novo Nordisk A/S
Responsible party
Sponsor
First posted
Oct 9, 2026
Start date
Oct 8, 2026
Primary completion
Sep 7, 2028 (estimated)
Completion
Sep 7, 2028 (estimated)
Last update
Oct 16, 2026

Study contacts

Novo Nordisk
Contact
clinicaltrials@novonordisk.com
(+1) 866-867-7178
Clinical Transparency (dept. 2834)
study director · Novo Nordisk A/S

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Tirzepatide · Zenagamtide

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