60 Participants NeededMy employer runs this trial

Zenagamtide + Tirzepatide for Obesity

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Novo Nordisk A/S
Must be taking: Tirzepatide
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how well the drug zenagamtide works for individuals who are overweight or have obesity and are already using tirzepatide. The goal is to determine the best dose of zenagamtide to switch to after tirzepatide. All participants will receive both drugs. It suits those who have maintained a stable dose of tirzepatide for at least four weeks, and some may also have type 2 diabetes managed with specific oral medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that tirzepatide is generally safe for most people. In studies, it helped many people lose weight and was usually well-tolerated. Most side effects were mild and mainly affected the stomach, such as nausea or diarrhea.

Detailed safety information for zenagamtide is not yet available. The trial is in the early stages, so researchers are still learning about its safety in humans. This phase is crucial for identifying any unexpected issues when people first use the treatment.

Researchers are testing these treatments together to determine their effectiveness and safety for weight management.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about tirzepatide and zenagamtide for obesity because they offer a fresh approach compared to existing treatments like lifestyle changes, medications such as orlistat, and surgical options like bariatric surgery. Tirzepatide is unique because it is a dual agonist, meaning it targets two different hormones that regulate insulin and appetite, potentially enhancing weight loss. Zenagamtide, on the other hand, offers a novel mechanism by acting as a gut hormone analog, which may help improve metabolism and reduce food intake. Together, these treatments could offer a more effective and convenient option for managing obesity, as they are administered via once-weekly injections, simplifying the treatment regimen.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that tirzepatide effectively aids weight loss in people with obesity. Studies found that participants using tirzepatide lost over 22% of their body weight on average and experienced significant improvements in body shape. Approximately 78% of participants lost at least 5% of their weight, with many losing even more. Although newer and less researched, zenagamtide is believed to help by reducing appetite and boosting metabolism. In this trial, participants will receive both tirzepatide and zenagamtide, aiming to provide a robust combined approach to managing obesity.678910

Who Is on the Research Team?

CT

Clinical Transparency (dept. 2834)

Principal Investigator

Novo Nordisk A/S

Are You a Good Fit for This Trial?

This trial is for adults who are overweight or have obesity, with or without type 2 diabetes, and are already taking tirzepatide. Participants must be able to safely switch from their current medication as determined by the study team.

Inclusion Criteria

Considered eligible based on medical history, physical examination, vital signs, electrocardiogram, and clinical laboratory tests during screening as judged by the investigator
I am 18 years old or older.
My sex assigned at birth is male or female.
See 3 more

Exclusion Criteria

I have not used any restricted medications in the past 14 days, except allowed ones.
I am not pregnant, breastfeeding, or at risk of pregnancy without contraception.
I do not have other conditions causing similar stomach or gut symptoms as GLP-1 RA side effects.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tirzepatide followed by zenagamtide, each administered once weekly by subcutaneous injection

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Tirzepatide
  • Zenagamtide

Trial Overview

The study tests how well people tolerate switching from tirzepatide to different doses of a new drug called zenagamtide. All participants will receive both medications during the trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Tirzepatide and ZenagamtideExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Novo Nordisk A/S

Lead Sponsor

Trials
1,578
Recruited
3,813,000+
Lars Fruergaard Jørgensen profile image

Lars Fruergaard Jørgensen

Novo Nordisk A/S

Chief Executive Officer since 2017

MSc in Finance and Business Administration, Aarhus School of Business, Aarhus University, Denmark

Martin Holst Lange profile image

Martin Holst Lange

Novo Nordisk A/S

Chief Medical Officer since 2021

MD from University of Copenhagen

Citations

Weight Loss Dynamics and Health Burden Changes with ...

Patients treated with tirzepatide lost more weight than those treated with semaglutide (mean reduction, 14.7% vs. 10.8%; p<0.001).

Tirzepatide demonstrated significant and superior weight ...

Participants receiving tirzepatide had a total mean weight reduction of 24.3% from study entry after 12 weeks of intensive lifestyle ...

Effects of Tirzepatide on Body Composition, Metabolic ...

In this prospective real-world study, tirzepatide treatment over approximately one year resulted in consistent improvements across adiposity, ...

Tirzepatide Demonstrates Significant Benefits for Patients ...

Results found that tirzepatide achieved substantial average weight loss of 22.9% at the 15 mg dose, with 99% of participants remaining diabetes- ...

Efficacy and Safety of Tirzepatide for the Management of Obesity

tirzepatide is an effective pharmacologic option for obesity treatment, demonstrating statistically significant reductions in mean body weight ...

Efficacy and Safety of Tirzepatide in Type 2 Diabetes ... - PMC

In people without diabetes, tirzepatide 5 to 15 mg once weekly for the treatment for obesity (SURMOUNT-1) resulted in substantial reductions in body weight ( ...

Efficacy and Safety of Tirzepatide and Semaglutide for ...

Tirzepatide and semaglutide were both associated with weight reduction in obesity, with greater reductions observed with tirzepatide, ...

Efficacy and safety of tirzepatide for weight loss in patients ...

Aggregated data indicated that tirzepatide treatment was correlated with higher likelihood of achieving ≥5% body weight loss comparing with ...

Review Comparative safety and side effects of semaglutide ...

[143] demonstrated that Tirzepatide followed by Semaglutide highly improved the Impact of Weight on Quality of Life-Lite (IWQOL-Lite) total scores that results ...

Novo Nordisk's new weight loss treatment inferior to tirzepatide

The treatment was safe and well tolerated, with mostly mild to moderate gastrointestinal adverse effects reported, consistent with other GLP-1s ...