Zenagamtide for Obesity
(AMAZE 9 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether zenagamtide, a new oral medication, is safe and effective for individuals with excess body weight. Participants will take either zenagamtide or a placebo (a pill with no active medicine) once daily, alongside a reduced-calorie diet and increased physical activity. The goal is to determine if zenagamtide aids in weight loss. The trial seeks participants without diabetes who have not used certain diabetes medications. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking weight loss treatment.
Is there any evidence suggesting that zenagamtide is likely to be safe for humans?
Research has shown that zenagamtide has been studied for its safety and effects on weight loss. In earlier studies, zenagamtide led to significant weight loss and improved blood sugar control. While promising, some participants experienced common side effects, such as nausea, vomiting, and diarrhea.
GLP-1 receptor agonists, the group of drugs that includes zenagamtide, are generally considered safe and effective for treating type 2 diabetes and obesity. As zenagamtide undergoes more advanced trials, additional information about its safety will emerge. Participants should consider these points when deciding whether to join a clinical trial.12345Why do researchers think this study treatment might be promising for obesity?
Unlike the standard treatments for obesity, which often include lifestyle changes and medications like orlistat or GLP-1 receptor agonists, Zenagamtide offers a fresh approach. This experimental drug is taken orally once daily and is designed to work alongside a reduced-calorie diet and increased physical activity. Researchers are excited about Zenagamtide because it may target obesity differently, potentially leading to improved weight management outcomes. Its unique formulation and method of action could provide a new option for those struggling with obesity, setting it apart from existing therapies.
What evidence suggests that zenagamtide might be an effective treatment for obesity?
Studies have shown that zenagamtide can lead to significant weight loss. In some trials, participants taking the drug lost about 17.4% more body weight compared to those taking a placebo, which contains no active ingredients. This indicates that the drug effectively aids in weight loss. Zenagamtide belongs to a group of medications that have shown promise in reducing body weight by affecting appetite and metabolism. Previous research with similar medications has demonstrated weight loss ranging from 4% to over 10%. This evidence strongly supports zenagamtide's potential effectiveness in treating obesity. Participants in this trial will receive one of five dose levels of zenagamtide or a placebo, alongside a reduced-calorie diet and increased physical activity.678910
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 adults aged 18 and older who have excess body weight. People with diabetes or those already taking certain weight-loss medications (like GLP-1, GIP receptor agonists, or amylin analogues) cannot participate.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 placebo orally once daily 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
- Zenagamtide
Trial Overview
The study tests whether zenagamtide tablets help people lose weight compared to a placebo tablet with no active medicine. Participants are randomly assigned to one of the two groups and take their assigned tablet once daily.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants will be randomized to receive 1 of the 5 dose levels of zenagamtide orally once daily as an adjunct to a reduced-calorie diet and increased physical activity.
Participants will receive placebo matched to zenagamtide orally once daily 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
1.
researchgate.net
researchgate.net/publication/360349639_Efficacy_of_GLP-1_RA_Approved_for_Weight_Management_in_Patients_With_or_Without_Diabetes_A_Narrative_Review(PDF) Efficacy of GLP-1 RA Approved for Weight ...
The mean weight loss difference between GLP-1 RAs and placebo as add-on to lifestyle intervention in patients with diabetes was 4% to 6.2% ...
Novo Nordisk to test zenagamtide against its own ...
The largest of the three, named AMBIENCE, is a cardiovascular outcomes trial in 8,500 patients who have established heart disease and are ...
A Research Study Investigating How Well the Medicine ...
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 ...
4.
medcitynews.com
medcitynews.com/2025/03/novo-nordisks-next-gen-obesity-drug-disappoints-again-with-lower-than-expected-weight-loss/Novo Nordisk's Next-Gen Obesity Drug Disappoints Again ...
Results showed 17.4% placebo-adjusted weight loss at 68 weeks. Novo Nordisk said Monday that detailed results from both CagriSema Phase 3 ...
5.
researchgate.net
researchgate.net/publication/380542600_Long-term_weight_loss_effects_of_semaglutide_in_obesity_without_diabetes_in_the_SELECT_trial(PDF) Long-term weight loss effects of semaglutide in ...
At 208 weeks, semaglutide was associated with mean reduction in weight (−10.2%), waist circumference (−7.7 cm) and waist-to-height ratio (−6.9% ...
Zenagamtide Targets Key Feeding-Related Brain Regions ...
In free-choice rats, zenagamtide decreased body weight by -13% vs vehicle (p<0.001). Free-choice rats overconsumed fructose water and this ...
Zenagamtide Tablets for Weight Loss - TrialFinder
FDA approval. Prior Safety Data. The purpose of this clinical study is to find out if zenagamtide is safe and effective
8.
veloxpeps.com
veloxpeps.com/guides/retatrutide-vs-zenagamtide-amycretin/?srsltid=AU7gw4U0AvKLiuJWxdFrKt3kUzyguiQ0xcy0decZ41yA93ozatv2ewjwRetatrutide vs Zenagamtide (Amycretin)
Zenagamtide's most advanced published diabetes data is still Phase 2b, reporting a smaller 14.6% weight loss and 1.71-point A1C reduction. The ...
9.
medicaldialogues.in
medicaldialogues.in/diabetes-endocrinology/news/zenagamtide-shows-strong-glycemic-control-and-weight-loss-in-phase-2-trial-172258Zenagamtide Shows Strong Glycemic Control and Weight ...
Up to 89.1% of participants achieved an HbA1c below 7%, while those receiving the highest dose (40 mg) experienced up to 14.6% body weight loss ...
GLP-1 medications: Treatments and side effects
As FDA-approved medications, GLP-1 RAs are a safe and effective treatment for: Type 2 diabetes; Chronic weight management; Obstructive sleep ...
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.