AMG 786 for Obesity

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the safety and tolerability of AMG 786, a new treatment tested for obesity. Participants will receive either AMG 786 or a placebo in varying doses to observe their body's reactions. The trial includes different groups, such as those taking the treatment under various conditions, like with or without food. Suitable candidates for this trial have a stable body weight and a BMI between 25 and 32, without major health issues like diabetes or heart disease. As a Phase 1 trial, this research focuses on understanding how AMG 786 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that AMG 786 is likely to be safe for humans?

Research has shown that AMG 786 was tested for safety in both single and multiple doses in healthy and overweight individuals. The main goal was to assess how well participants tolerated the treatment. However, Amgen, the company behind AMG 786, chose not to continue its development for obesity after the initial results. This decision might indicate safety concerns or other issues, but specific details about side effects or problems were not provided. As this was an early study, the safety information remains limited, and more data would be necessary to fully understand its effects on people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

AMG 786 is unique because it offers a novel approach to tackling obesity through its innovative mechanism of action. Unlike traditional treatments like lifestyle changes, medications such as orlistat, or surgical options that work by reducing appetite or blocking fat absorption, AMG 786 targets specific pathways in the body to potentially regulate weight more effectively. Researchers are excited about its potential to provide a more precise and possibly quicker impact on weight management, offering hope for those struggling with obesity.

What evidence suggests that AMG 786 might be an effective treatment for obesity?

Initial findings suggest that researchers are studying AMG 786 for its potential to treat obesity, focusing on the drug's tolerability. The research aims to determine its safety for both healthy and obese participants. Participants in this trial will receive either AMG 786 or a placebo in different dosing cohorts. However, limited information exists on AMG 786's effectiveness for weight loss. Amgen, the company developing AMG 786, has decided to stop focusing on this drug after early results. They are now concentrating on another treatment called MariTide, which has shown promising weight loss results in other studies. ^{1 4 5 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05406115

Single and Multiple Ascending Dose Study to Evaluate ... Single and Multiple Ascending Dose Study to Evaluate AMG 786 in Healthy Participants and Participants With Obesity · Study Overview · Contacts and Locations.

2. amgentrials.com amgentrials.com/study/?id=20210011

Single and Multiple Ascending Dose Study to Evaluate ... The primary objective of this study is to assess the safety and tolerability of AMG 786 as single or multiple doses in healthy and obese participants.

3. fiercebiotech.com fiercebiotech.com/biotech/amgen-axes-obesity-asset-after-ph-1-results-zooms-maritide

Amgen axes an obesity asset, zooms in on MariTide Amgen is axing obesity candidate AMG 786 and going all in on later-stage asset MariTide.

4. withpower.com withpower.com/trial/phase-1-obesity-6-2022-26e52

AMG 786 for Obesity · Info for Participants It aims to see how well people tolerate this new drug. Participants in 4 cohorts will receive either AMG 786 or placebo in Multiple Ascending Doses.

5. amgen.com amgen.com/newsroom/press-releases/2024/11/amgen-announces-robust-weight-loss-with-maritide-in-people-living-with-obesity-or-overweight-at-52-weeks-in-a-phase-2-study

Press Releases MariTide demonstrated up to ~20% average weight loss at week 52 without a weight loss plateau, indicating the potential for further weight loss beyond 52 weeks.

6. synapse.patsnap.com synapse.patsnap.com/drug/0b7392572d21456c895fa83af8abacba

AMG-786 - Drug Targets, Indications, Patents In February 2024, Amgen published Phase I data for MariTide showing that the investigational treatment could cut body weight by 14.5% at 85 days in obese ...

7. adisinsight.springer.com adisinsight.springer.com/drugs/800068757

AMG 786 - AdisInsight - Springer AMG 786 was an orally available small molecule therapeutic being developed by Amgen for the treatment of obesity.