What side effects are associated with this type of intervention?

Common pharmacological treatments for obesity, such as GLP-1 receptor agonists (e.g., liraglutide), combination therapies (e.g., phentermine-topiramate), and other agents (e.g., metformin, topiramate), have various side effects. GLP-1 receptor agonists can cause gastrointestinal issues like nausea, vomiting, and diarrhea, and have been associated with pancreatitis. Phentermine-topiramate may lead to increased heart rate, insomnia, dry mouth, and constipation. Metformin is generally well-tolerated but can cause gastrointestinal disturbances such as diarrhea and abdominal discomfort. Topiramate may result in cognitive side effects, such as memory impairment and difficulty concentrating, as well as paresthesia and weight loss.

What prior FDA approvals exist?

The FDA has approved several pharmacological agents for the treatment of obesity. Notable among these are GLP-1 receptor agonists like liraglutide, which has shown efficacy in weight loss and glycemic control. Another combination therapy includes phentermine-topiramate, which has demonstrated significant weight loss in clinical trials. These treatments, like AMG 786, are evaluated for their safety and tolerability in both healthy and obese individuals.

What other types of research exist?

Promising novel alternatives to AMG 786 for obesity treatment in 2024 include: 1) Semaglutide, a GLP-1 receptor agonist, which has shown significant weight loss in clinical trials. 2) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has demonstrated superior weight loss compared to existing treatments. 3) Setmelanotide, a melanocortin 4 receptor agonist, specifically for patients with genetic obesity disorders. These medications have shown efficacy and safety in recent studies and are expected to be key options for obesity management.

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Unknown

AMG 786 for Obesity

Phase 1

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female participants must be of non-childbearing potential (postmenopausal defined as: Age of ≥ 55 years with no menses for at least 12 months; OR Age < 55 years with no menses for at least 12 months AND with a follicle-stimulating hormone (FSH) level > 40 IU/L or according to the definition of 'postmenopausal range' for the laboratory involved; OR History of hysterectomy; OR History of bilateral oophorectomy

Age 18 to 65 years at the time of signing the informed consent

Must not have

History of major depressive disorder

History of gastrointestinal (GI) abnormality that could affect GI motility (including small bowel or colonic resection, inflammatory bowel disease, irritable bowel disease, and colon or GI tract cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 through end of study (approximately 40 days)

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, common ones may include reactions at the injection site, gastrointestinal discomforts such as nausea or diarrhea, headaches, fatigue, and possible allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with major depressive disorder.

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I have a history of GI issues that could affect how my stomach and intestines move food.

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I have a history of heart disease or heart failure.

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My obesity is caused by an endocrine disorder like Cushing's Syndrome.

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I have diabetes or my blood sugar/HbA1c levels are high.

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My liver tests are not more than 1.5 times the normal limit and I don't have Gilbert's disease.

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I have kidney problems or my kidney function is low.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 through end of study (approximately 40 days)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 through end of study (approximately 40 days)

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 through end of study (approximately 40 days) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part B: Multiple Ascending Dose CohortsExperimental Treatment2 Interventions

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

Group II: Part A: Single Ascending Dose CohortsExperimental Treatment2 Interventions

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

Group III: Part A: Food Effect CohortExperimental Treatment2 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

AMG 786

2022

Completed Phase 1

~70

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common pharmacological treatments for obesity include GLP-1 receptor agonists, phentermine-topiramate, and orlistat. GLP-1 receptor agonists, such as semaglutide, work by mimicking the incretin hormone, which increases insulin secretion, decreases glucagon release, and slows gastric emptying, leading to reduced appetite and caloric intake. Phentermine-topiramate combines an appetite suppressant with an anticonvulsant, enhancing weight loss by reducing hunger and increasing satiety. Orlistat inhibits pancreatic lipase, reducing fat absorption from the diet. These mechanisms are crucial for obesity patients as they target different aspects of weight regulation, helping to achieve and maintain significant weight loss, which is essential for improving overall health and reducing obesity-related comorbidities.

[Action mechanisms of anti-obesity drugs].