Recruiting
Phase 1

Tirzepatide & Zenagamtide

Sponsor:

Novo Nordisk A/S

Code:

NCT07868354

Conditions

Overweight

Obesity

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tirzepatide

Zenagamtide

Study Details

Brief 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.

Conditions

Overweight

Obesity

Type 2 Diabetes

Study ID

NCT07868354

Start date

Oct 8, 2026

Status verified date

Oct, 2026

Completion date

Sep 7, 2028

Anticipated

Primary completion date

Sep 7, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

60 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Tirzepatide

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

Zenagamtide

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

Primary outcome measure

  • Number of treatment emergent adverse events (TEAE) [ Time Frame: From first administration of zenagamtide day 1 to day 57 ]

Central Contacts and Locations

Locations

PAREXEL Glendale/LA EPCU

Recruiting

Glendale, California, United States, 91206

PAREXEL Intl - EPCU-Baltimore

Recruiting

Baltimore, Maryland, United States, 21225

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Oct 16, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-17. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2026-10-16. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.