AMG 786 for Obesity

Recruiting at 3 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Disqualifiers: Diabetes, Hypertension, Renal impairment, others

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

Compensation: Varies

Number of Visits: 2

65 Participants Needed

Trial Summary

Do I need to stop taking my current medications for the AMG 786 trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What safety data exists for AMG 786 or similar treatments for obesity?

The research highlights that many anti-obesity medications have been associated with serious side effects, including heart and kidney problems, and some have been withdrawn from the market due to these issues. It is important to continue monitoring the safety of these treatments to ensure they are safe for patients. ^{1 2 3 4 5}

What is the purpose of this trial?

This trial is testing a new drug called AMG 786 to see if it is safe for healthy and obese people to use. The study aims to understand if the drug is well-tolerated in these groups.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

This trial is for healthy adults or those with obesity, aged 18-65, who have a stable weight and are not of childbearing potential. Participants must be free from serious health issues like heart disease, uncontrolled thyroid disorders, severe psychiatric conditions, and cannot have had previous obesity surgery.

Inclusion Criteria

I am a woman who cannot become pregnant due to menopause or surgery.

Participant has provided informed consent/assent prior to initiation of any study-specific activities/procedures

Have a stable body weight (less than 5 kg self-reported change during the previous 8 weeks) prior to screening

Exclusion Criteria

Positive results for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C virus ribonucleic acid (RNA). For hepatitis C, hepatitis C antibody (HepCAb) testing is done at screening, followed by hepatitis C virus RNA by polymerase chain reaction (PCR) if hepatitis C antibody is positive

I have no major surgeries planned during the trial, except minor ones approved by the trial's medical team.

I have been diagnosed with major depressive disorder.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Ascending Dose

Participants receive either AMG 786 or placebo in Single Ascending Doses

Approximately 11 days

2 visits (in-person)

Multiple Ascending Dose

Participants receive either AMG 786 or placebo in Multiple Ascending Doses

Approximately 40 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• AMG 786
• Placebo

Trial Overview The study tests the safety of AMG 786 in single or multiple doses compared to a placebo in both healthy participants and those with obesity. It aims to see how well people tolerate this new drug.

Participant Groups

Group I: Part B: Multiple Ascending Dose Cohorts Experimental Treatment 2 Interventions

Participants in 4 cohorts will receive either AMG 786 or placebo in Multiple Ascending Doses.

Group II: Part A: Single Ascending Dose Cohorts Experimental Treatment 2 Interventions

Participants in 4 cohorts will receive either AMG 786 or placebo in Single Ascending Doses.

Group III: Part A: Food Effect Cohort Experimental Treatment 2 Interventions

Participants in the food effect cohort (FEC) will receive 1 of 2 AMG 786 in 1 of two sequences. Participants in Sequence 1 will receive a dose of AMG 786 on day 1 under fed conditions followed by a 10-day washout period and another dose of AMG 786 on day 11 under fasted conditions. Participants in Sequence 2 in the FEC cohort will receive the first dose on day 1 under fasted conditions and the second dose on day 11 under fed conditions.

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

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]

In a 16-week study involving 140 overweight adults, the herbal extract LI85008F led to significant weight loss (5.36 kg) and reductions in BMI compared to a placebo group, indicating its efficacy for weight management.

Participants taking LI85008F also experienced improvements in their lipid profiles, with decreased LDL cholesterol and increased HDL cholesterol, and no major adverse events were reported, highlighting its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a novel herbal formulation for weight loss demonstrated in a 16-week randomized, double-blind, placebo-controlled clinical trial with healthy overweight adults. Dixit, K., Kamath, DV., Alluri, KV., et al.[2019]

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]

Obesity is linked to numerous serious health issues, yet the demand for safe and effective antiobesity drugs is rising as obesity rates continue to climb globally.

Previous antiobesity drugs have faced significant safety concerns, leading to withdrawals due to life-threatening side effects, highlighting the need for better predictive models and new therapeutic targets in drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review paper: Current strategies in the development of anti-obesity drugs and their safety concerns. Elangbam, CS.[2008]

Recent anti-obesity medications have been linked to adverse cardiovascular outcomes, prompting a need for thorough cardiovascular safety evaluations in clinical trials.

Current cardiovascular outcome trials for weight loss medications, including novel diabetes treatments, show limited data and unsatisfactory results, highlighting the need for improved trial designs to better assess safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Safety and Superiority of Anti-Obesity Medications. Alobaida, M., Alrumayh, A., Oguntade, AS., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

Efficacy of a novel herbal formulation for weight loss demonstrated in a 16-week randomized, double-blind, placebo-controlled clinical trial with healthy overweight adults. [2019]

3. 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]

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

Review paper: Current strategies in the development of anti-obesity drugs and their safety concerns. [2008]

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

Cardiovascular Safety and Superiority of Anti-Obesity Medications. [2023]