AMG 513 for Obesity

Recruiting at 5 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Disqualifiers: Diabetes, High triglycerides

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called AMG 513, a potential drug for obesity, to determine its safety and tolerability. The study consists of two parts: one tests a single dose, and the other tests multiple doses. Both parts focus on individuals who are obese or overweight. Suitable candidates include adults with a body mass index (BMI) between 27 and 40, excluding those with diabetes or very high triglycerides (a type of fat in the blood). As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that AMG 513 is likely to be safe for humans?

Research shows that AMG 513 is undergoing testing for safety in individuals with obesity. Earlier studies aimed to observe reactions to varying doses of AMG 513, administered either once or multiple times. Although specific results from these studies are not available, they are early-stage, focusing on initial safety in humans. Some participants have already tried the treatment, but scientists continue to gather information to ensure its safety. Joining this clinical trial would contribute to researchers' understanding of the treatment's safety. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Unlike the standard treatments for obesity, which often include lifestyle changes, medications like orlistat or GLP-1 receptor agonists such as semaglutide, AMG 513 introduces a novel approach. Researchers are excited about AMG 513 because it offers a unique mechanism of action or delivery method that could potentially enhance weight loss efficiency. This could mean a more targeted approach with possibly fewer side effects. Additionally, the dual application via subcutaneous and intravenous methods offers flexibility in administration, which might lead to better patient compliance and outcomes.

What evidence suggests that AMG 513 might be an effective treatment for obesity?

Research shows that AMG 513 is being developed as a potential treatment for obesity. It may work by affecting pathways related to heart and metabolism conditions, potentially aiding weight management by altering how the body uses energy and fat. However, limited data currently exist on its effectiveness in humans. In this trial, participants will enroll in either the Single Ascending Dose (SAD) or Multiple Ascending Dose (MAD) arms and will be randomized to receive AMG 513 or a placebo. The main focus of current research is to ensure the drug is safe and well-tolerated by people. So far, no solid evidence supports its effectiveness in weight loss. ^{1 2 4 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for men and women aged 18 to 65 with obesity, defined as having a BMI between ≥30 and ≤40. Women must be unable to bear children. It's not specified who can't join the trial.

Inclusion Criteria

I cannot become pregnant.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose (SAD)

Participants receive a single ascending dose of AMG 513 or placebo subcutaneously or intravenously

4 weeks

Multiple Ascending Dose (MAD)

Participants receive multiple ascending doses of AMG 513 or placebo subcutaneously

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AMG 513

Trial Overview The study is testing AMG 513, a potential new treatment for obesity. Participants will receive either AMG 513 or a placebo without any active drug in it, to compare effects on safety and tolerability after one dose and several doses over time.

How Is the Trial Designed?

Group I: Single Ascending Dose (SAD) in Participants with Obesity (Part A) Experimental Treatment 2 Interventions

In Part A participants will enroll into SAD cohorts and will be randomized to receive AMG 513 or placebo subcutaneously (SC) or intravenously (IV).

Group II: Multiple Ascending Dose (MAD) in Participants with Overweight or Obesity (Part B) Experimental Treatment 2 Interventions

In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC.

AMG 513 is already approved in United States for the following indications:

Approved in United States as AMG 513 for:

• None approved; currently in Phase 1 clinical trials for obesity

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

A study of 806 participants from the Boston Puerto Rican Health Study identified 179 metabolites that differ between individuals with type 2 diabetes (T2D) and those without, with 120 metabolites unique to those with abdominal obesity.

The research found that higher consumption of energy-dense takeout food, dairy, and sugar-sweetened beverages was linked to specific metabolic pathways associated with T2D, highlighting the connection between dietary habits and the risk of developing T2D.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolite patterns link diet, obesity, and type 2 diabetes in a Hispanic population. Parnell, LD., Noel, SE., Bhupathiraju, SN., et al.[2022]

A one-year multimodal treatment program for severe obesity (BMI≥35.0 kg/m²) involving 190 participants showed significant improvements in body weight, waist circumference, eating disorder psychopathology, and quality of life from pre-treatment to post-treatment, with benefits maintained at a one-year follow-up.

Despite the promising results of the program, high rates of participant drop-out during the study limit the ability to draw strong conclusions, highlighting the need for further evaluations to strengthen the evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evaluation of the One-Year Multimodal Weight Loss Program DOC WEIGHT® 1.0 for Obesity Class II and III]. Rudolph, A., Hellbardt, M., Baldofski, S., et al.[2019]

Research from Clinical Research Centers over the past 20 years has significantly advanced our understanding of obesity, highlighting that early onset obesity is linked to an increase in fat cell numbers, while weight loss primarily reduces fat cell size.

Obesity is associated with various health complications, including Type II diabetes and hypertension, and while obese individuals may consume more food, they also have higher basal metabolic rates that can increase with overfeeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity. Dietz, WH.[2019]

Long-acting GLP-1 receptor agonists, such as liraglutide and semaglutide, are effective anti-obesity medications that can lead to significant weight loss, with semaglutide showing an average weight loss of 11.6% after one year, compared to 5.5% with liraglutide.

Both medications are generally well tolerated, with similar safety profiles, though they can cause transient gastrointestinal issues; ongoing long-term studies are needed to further evaluate their efficacy and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists. Christensen, RM., Juhl, CR., Torekov, SS.[2020]

A comprehensive analysis of the FDA Adverse Event Reporting System revealed 18,675 unique adverse event reports linked to anti-obesity medications (AOMs) among 15,143 patients, highlighting significant safety concerns.

Serious adverse events included a fatality ratio of 4.9%, with cardiovascular complications being particularly prevalent, accounting for 31% of AEs related to phentermine, and indicating a need for ongoing safety monitoring of AOMs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Descriptive analysis of reported adverse events associated with anti-obesity medications using FDA Adverse Event Reporting System (FAERS) databases 2013-2020. Alsuhibani, A., Alrasheed, M., Gari, M., et al.[2022]

New generation anti-obesity medications, such as orlistat, phentermine/topiramate, and liraglutide 3.0 mg, have varying safety profiles, with some presenting significant risks like fetal toxicity and gallstone disease, while others mainly cause transient tolerability issues.

Despite their effectiveness in weight loss, the prescription rates for these medications are low, partly due to safety concerns and the need for more long-term data to better understand their risk-benefit profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. Patel, DK., Stanford, FC.[2023]

In a study of 129 patients with severe obesity (BMI ≥ 40 kg/m²), semaglutide 2.4 mg treatment led to a significant average weight loss of 9.1% over 24 weeks, showing its effectiveness in this population.

There was no significant difference in weight loss between patients who had previously undergone bariatric surgery and those who had not, indicating that semaglutide can be a viable treatment option for both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Semaglutide 2.4 mg/wk for weight loss in patients with severe obesity and with or without a history of bariatric surgery. Bonnet, JB., Tournayre, S., Anitcheou, J., et al.[2023]

Interdisciplinary long-term programs involving physicians, psychologists, physiotherapists, and dieticians are essential for effectively treating obesity and improving patient outcomes.

Combination treatments, such as formula diets followed by reduction diets and behavioral therapy with physiotherapy, have shown to be successful in reducing obesity and its associated health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Successful treatment of obesity]. Wechsler, JG., Leopold, K., Bischoff, G.[2019]

Bariatric surgery is a safe and effective treatment for class II and III obesity, with experienced surgeons achieving weight reductions of about 50% with restrictive procedures and up to 75% with combined methods.

Long-term studies show that bariatric surgery significantly improves or eliminates obesity-related health issues and enhances quality of life, with a low perioperative mortality rate of 0.2-1.0% and a maximum morbidity rate of 20%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Surgical procedures for severely obese patients: impact and long-term results]. Potoczna, N., Steffen, R., Horber, FF.[2019]

Obesity, defined as a body mass index of 30 kg/m2 or higher, is a growing global epidemic linked to various health issues and reduced quality of life.

Effective treatment for obesity should be personalized and may include a hypocaloric diet, increased physical activity, behavior modification, and potentially weight-loss medications, which can improve health outcomes and extend life expectancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Obesity--a somatic or psychological condition or both?]. Hauner, H.[2007]

Transgenic mouse models have provided valuable insights into the genetic and molecular mechanisms of obesity, revealing that obesity can occur without increased food intake (hyperphagia) and that different genes can influence energy balance in complex ways.

The Type 1 11beta-hydroxysteroid dehydrogenase over-expressing mouse is highlighted as a key model for studying metabolic syndrome in humans, which may help guide future research and treatment strategies for obesity in people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons in obesity from transgenic animals. Arch, JR.[2018]

A total of 25 anti-obesity medications were withdrawn between 1964 and 2009, primarily due to adverse reactions related to their effects on monoamine neurotransmitters, with 80% of withdrawals supported by case reports.

The most common reasons for withdrawal included psychiatric disturbances, cardiotoxicity, and drug dependence, raising concerns about the safety of using medications that target neurotransmitters for obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. Onakpoya, IJ., Heneghan, CJ., Aronson, JK.[2022]

Obesity significantly increases the risk of serious metabolic complications, including diabetes, cardiovascular disease, and liver issues, which contribute to higher mortality rates among obese individuals.

Centralized obesity, indicated by a high waist-to-hip ratio, is particularly dangerous as it is linked to increased morbidity and mortality, primarily due to insulin resistance and its effects on overall health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Consequences and complications of obesity]. Simon-Vermot, I., Keller, U.[2008]

Losing just 5% of body weight can lead to significant health improvements, but many individuals struggle to maintain weight loss through diet and exercise alone, highlighting the need for additional treatment options.

As of 2012, two new medications, lorcaserin and phentermine/topiramate, have been approved for long-term obesity treatment, and bariatric surgery is recommended for patients with severe obesity (BMI ≥40 or ≥35 with comorbidities) as a more intensive intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm. Kushner, RF., Apovian, CM., Fujioka, K.[2018]

Obesity is a significant global health issue linked to increased risks of atherosclerosis, various cancers, and decreased life expectancy, particularly affecting younger adults more severely than older ones.

Around 30% of obese individuals can be metabolically healthy, showing insulin sensitivity similar to normal-weight individuals, which highlights the complexity of obesity's health impacts and the importance of fat distribution in assessing health risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Definition and Prevalence of Obesity and Metabolic Syndrome. Engin, A.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06585462

Single and Multiple Ascending Dose Study of AMG 513 in ... In Part B participants will enroll into MAD cohorts and will be randomized to receive AMG 513 or placebo SC. AMG 513 will be administered by SC injection.

2. amgentrials.com amgentrials.com/study/?id=20230022

Single and Multiple Ascending Dose Study of AMG 513 in ... The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.

3. biospace.com biospace.com/business/amid-obesity-bidding-war-amgen-believes-it-can-stand-out-in-crowded-space

Amid Obesity Bidding War, Amgen Believes It Can Stand ... Aside from MariTide, Amgen's obesity push also includes the injectable AMG 513, though not much is known about the asset. Its development had ...

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/AMGN/pressreleases/35739102/amgens-amg-513-study-a-potential-game-changer-in-obesity-treatment/

Amgen's AMG 513 Study: A Potential Game-Changer in ... The study aims to assess the safety and tolerability of AMG 513, a potential treatment for cardiometabolic disease, in individuals with obesity.

5. statnews.com statnews.com/2025/02/04/amgen-early-obesity-candidate-paused-by-fda/

Study of Amgen's early obesity candidate paused by FDA | STAT Amgen said Tuesday that the Food and Drug Administration has ordered a hold on a study of the company's early-stage obesity candidate.

6. ctv.veeva.com ctv.veeva.com/study/single-and-multiple-ascending-dose-study-of-amg-513-in-participants-with-obesity

Single and Multiple Ascending Dose Study of AMG 513 in ... The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.

7. trial.medpath.com trial.medpath.com/drug/6b9b2cc03d70759a/amg-513

AMG-513 - MedPath AMG-513 is an early-stage investigational therapeutic agent currently under development by Amgen for the treatment of obesity.[1] This candidate ...