60 Participants NeededMy employer runs this trial

Zenagamtide for Obesity

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Novo Nordisk A/S
Must be taking: Semaglutide
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 aims to determine the optimal dose of a new treatment, zenagamtide, for individuals who are overweight or have obesity, some of whom may also have type 2 diabetes. Participants will initially receive semaglutide, a known medication, and then switch to zenagamtide to assess their response. Suitable candidates for this trial should have maintained a steady dose of semaglutide (administered by injection) for at least four weeks. 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 semaglutide is usually well-tolerated by people with obesity. Studies have found it aids in weight loss and maintains a reasonable safety profile. Some reports indicate a higher likelihood of stomach issues, such as nausea, compared to a placebo. However, serious side effects, particularly heart problems, occurred less frequently with semaglutide than with a placebo.

Specific safety information for zenagamtide is not yet available, as it remains in the early stages of testing. Detailed safety data for humans is still being collected. Early-phase trials primarily focus on ensuring a new treatment's safety before assessing its effectiveness.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about Zenagamtide for obesity because it introduces a novel active ingredient that may offer a fresh approach to weight management. Unlike traditional treatments like lifestyle changes, medications, or surgery, which primarily focus on reducing calorie intake or altering metabolism, Zenagamtide explores a new pathway by potentially targeting different mechanisms in the body. Additionally, Zenagamtide is administered through a weekly subcutaneous injection, which could be more convenient compared to treatments requiring daily use. This innovative method might provide a more effective and manageable solution for individuals struggling with obesity.

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

Research shows that semaglutide helps people with obesity lose weight. Studies have found that individuals can lose between 15% and nearly 21% of their weight over about 18 months. Participants taking semaglutide also experienced a decrease in their Body Mass Index (BMI) and weight, along with improved blood sugar levels. In this trial, participants will initially receive semaglutide and then switch to zenagamtide, a newer treatment under investigation as a follow-up. Early evidence suggests that zenagamtide works similarly to help control weight.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 semaglutide. Participants should be generally healthy aside from these conditions.

Inclusion Criteria

Considered eligible based on medical history, physical examination, vital signs, electrocardiogram and clinical laboratory tests during screening, as judged by investigator
I have been on a stable dose of semaglutide injections for at least 4 weeks.
I was diagnosed with type 2 diabetes before joining this study.
See 3 more

Exclusion Criteria

I am currently taking medications that cause significant stomach or digestive symptoms.
I have a condition that causes stomach or gut symptoms similar to GLP-1 RA side effects.
I had to lower my semaglutide dose because of side effects and couldn't increase it again.
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 semaglutide followed by zenagamtide, administered once weekly by subcutaneous injection

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Semaglutide
  • Zenagamtide

Trial Overview

The study tests how well people tolerate switching from their current semaglutide medication 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: Semaglutide 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

Semaglutide and Tirzepatide for Obesity: Effectiveness and ...

For oral semaglutide, no CV outcome data exists for patients with obesity without diabetes; therefore, effects were derived from the SOUL trial,

Efficacy and safety of semaglutide on weight loss in obese or ...

Conclusion: Semaglutide indicated a significant weight loss with an acceptable safety for obese or overweight patients without diabetes.

Chronic Weight Management Trial Results | Wegovy ...

Wegovy® HD (semaglutide) injection 7.2 mg: Designed to deliver greater weight-loss results than the Wegovy® you know · Efficacy estimand: ~21% mean weight loss ...

Tirzepatide vs semaglutide and liraglutide for weight loss in ...

the weight loss ranged between 15% and nearly 21% after 72 weeks of treatment.17 , 26 This represented clinically significant greater and ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39248157/

Semaglutide use in people with obesity and type 2 diabetes ...

We found average decreases of 1.54 kg/m2 in BMI, 4.65 kg in weight and 0.75% in HbA1c for semaglutide users. The decreases were larger in ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38740993/

Long-term weight loss effects of semaglutide in obesity ...

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%) ...

Semaglutide and Cardiovascular Outcomes in Obesity ...

was found to reduce body weight by a mean of 15.2% among patients with overweight or obesity who did not have diabetes.18

A Systematic Review and Meta-Analysis of Randomized ...

Our results support the long-term use of semaglutide for the treatment of overweight/obesity in patients without diabetes. CRediT authorship ...

Efficacy and safety of subcutaneous semaglutide in adults ...

Subcutaneous semaglutide had significant benefits on weight loss with reasonable safety in overweight or obese adults.

Efficacy and Safety of Semaglutide for Weight Loss in ...

Secondary outcomes showed that the risk of developing gastrointestinal adverse events was 1.59 times more likely with semaglutide (RR 1.59, 95%CI [1.34, 1.88],