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

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to assess the safety and tolerability of AMG 513 after single and multiple doses.

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.

What data supports the idea that AMG 513 for Obesity is an effective drug?

The available research does not provide specific data on AMG 513 for Obesity, so we cannot determine its effectiveness compared to other treatments. However, the research mentions other drugs like lorcaserin and combination phentermine/topiramate, which have been approved for obesity treatment and show some effectiveness. Additionally, surgical procedures and multimodal programs are noted as effective for severe obesity, with significant weight loss and improved quality of life. ^{1 2 3 4 5}

What safety data is available for AMG 513 in treating obesity?

The provided research does not mention AMG 513 or AMG-513 specifically. The studies focus on other anti-obesity medications and their safety profiles, such as phentermine/topiramate, liraglutide, and semaglutide. These studies highlight various adverse events associated with these medications, including cardiovascular and kidney complications, gastrointestinal disorders, and other serious adverse events. However, there is no specific safety data available for AMG 513 in the provided research. ^{6 7 8 9 10}

Is the drug AMG 513 a promising treatment for obesity?

AMG 513 is a promising drug for obesity because it targets the health issues linked to obesity, such as diabetes, heart disease, and high blood pressure. By addressing these problems, AMG 513 could help improve the overall health and life expectancy of people with obesity. ^{11 12 13 14 15}

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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 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

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Obesity consults--comprehensive obesity management in 2013: understanding the shifting paradigm. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

[Successful treatment of obesity]. [2019]

3. Germany pubmed.ncbi.nlm.nih.gov

[Evaluation of the One-Year Multimodal Weight Loss Program DOC WEIGHT® 1.0 for Obesity Class II and III]. [2019]

4. Germany pubmed.ncbi.nlm.nih.gov

[Surgical procedures for severely obese patients: impact and long-term results]. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Post-marketing withdrawal of anti-obesity medicinal products because of adverse drug reactions: a systematic review. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Benefit-Risk Assessment of Obesity Drugs: Focus on Glucagon-like Peptide-1 Receptor Agonists. [2020]

8. Netherlands 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of new-generation anti-obesity medications: a narrative review. [2023]

10. United States 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. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Consequences and complications of obesity]. [2008]

12. United States pubmed.ncbi.nlm.nih.gov

Metabolite patterns link diet, obesity, and type 2 diabetes in a Hispanic population. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Obesity. [2019]

14. Italy pubmed.ncbi.nlm.nih.gov

Lessons in obesity from transgenic animals. [2018]

15. United States pubmed.ncbi.nlm.nih.gov

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