Zenagamtide for Obesity
(AMAZE 7 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether a new treatment, zenagamtide, is safe and effective for individuals with excess body weight. It compares zenagamtide to semaglutide, an existing weight management medication, by administering either zenagamtide or varying doses of semaglutide to participants, alongside a diet and exercise plan. Eligible participants should have experienced weight issues but must not have diabetes or have recently used certain diabetes treatments. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the development of a potentially groundbreaking treatment.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that zenagamtide is as safe as other drugs that help control appetite and digestion. In a previous study, most participants tolerated zenagamtide well. The most common side effects were mild, such as nausea or an upset stomach. Serious side effects occurred in 8% of participants, but no deaths were reported.
Semaglutide, a drug already approved for diabetes and weight management, has well-documented safety information. Most people experience manageable side effects like nausea, and serious risks are rare.
Zenagamtide appears to be well-tolerated, similar to semaglutide. Both treatments share similar safety profiles, making them promising options for managing obesity.12345Why are researchers excited about this trial's treatments?
Zenagamtide is unique because it introduces a fresh approach to tackling obesity. Unlike most current treatments that focus on appetite suppression or calorie absorption, Zenagamtide may work through a novel mechanism that researchers believe could enhance weight loss effectiveness. While semaglutide, a well-known treatment, serves as a comparator, Zenagamtide's potential lies in its distinct action and possibly improved outcomes, making it a promising new option in the fight against obesity.
What evidence suggests that this trial's treatments could be effective for obesity?
Research has shown that zenagamtide, one of the treatments under study in this trial, may aid in weight loss. In one study, participants who received a high dose of zenagamtide lost up to 14.6% of their body weight after 36 weeks. This weight loss significantly exceeded that of participants who did not take the drug. Zenagamtide also lowered blood sugar levels, which can assist in weight management. These findings suggest that zenagamtide could effectively treat obesity.13456
Who Is on the Research Team?
Clinical Transparency (dept. 2834)
Principal Investigator
Novo Nordisk A/S
Are You a Good Fit for This Trial?
This trial is for people who are overweight or have obesity, including children and adults. Participants should not have had bariatric surgery recently and must meet other health requirements set by the study team.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Zenagamtide or Semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Semaglutide
- Zenagamtide
Trial Overview
The study compares a new medicine called zenagamtide to semaglutide (an approved weight loss drug) and placebos. Participants are randomly assigned to one of these groups to see which treatment helps with weight loss and is safest.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Participants will receive Zenagamtide and placebo matched to semaglutide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Participants will receive semaglutide dose 1 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Participants will receive semaglutide dose 2 and placebo matched to zenagamtide subcutaneously once weekly as an adjunct to a reduced-calorie diet and increased physical activity.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Novo Nordisk A/S
Lead Sponsor
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
Novo Nordisk A/S
Chief Medical Officer since 2021
MD from University of Copenhagen
Citations
Novo Nordisk's investigational zenagamtide shows ...
participants treated with zenagamtide showed body weight loss up to 14.6% at week 36 with the highest dose investigated, weight reduction of up ...
Novo Nordisk reports Phase II data for zenagamtide in ...
For the key secondary endpoint, mean body weight declined by up to 14.6% (from a baseline of 99.2kg) in the 40mg zenagamtide group compared with ...
Efficacy and safety of once-daily oral zenagamtide, a novel ...
zenagamtide resulted in significantly greater weight loss than placebo. The oral formulation of zenagamtide also resulted in greater reductions in HbA1c than ...
NCT07668414 | A Research Study Investigating How Well ...
The purpose of this study is to find out if zenagamtide is safe and effective for treating participants who have excess body weight compared to treatment with ...
a multicentre, randomised, parallel, ...
zenagamtide produced significant dose-dependent reductions in bodyweight compared with placebo
6.
clinicaltrials.eu
clinicaltrials.eu/trial/a-study-to-evaluate-the-efficacy-and-safety-of-zenagamtide-in-people-with-obesity/A study to evaluate the efficacy and safety of zenagamtide ...
This study aims to evaluate the effectiveness and safety of a new medication for people living with Obesity. The investigation focuses on whether the drug ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.