Your session is about to expire
← Back to Search
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 through end of study (approximately 40 days)
Awards & highlights
Study Summary
This trial is testing a new drug to see if it is safe and tolerated in healthy and obese people.
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.Check my eligibility
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.See study design
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 belowSelect...
I am a woman who cannot become pregnant due to menopause or surgery.
Select...
I am between 18 and 65 years old.
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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Secondary outcome measures
AUC of Metabolite M5
Area Under the Concentration-time Curve (AUC) of AMG 786
Cmax of Metabolite M5
+3 moreTrial 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.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,616 Total Patients Enrolled
8 Trials studying Obesity
995 Patients Enrolled for Obesity
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,059 Total Patients Enrolled
5 Trials studying Obesity
832 Patients Enrolled for Obesity
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am considered postmenopausal based on my age, menstrual history, or surgical history.I am a woman who cannot become pregnant.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.I have a history of GI issues that could affect how my stomach and intestines move food.I am a woman who cannot become pregnant due to menopause or surgery.I have a history of heart disease or heart failure.My obesity is caused by an endocrine disorder like Cushing's Syndrome.I have diabetes or my blood sugar/HbA1c levels are high.I haven't had cancer, except for certain skin, cervical, or non-invasive breast cancers, in the last 5 years.My liver tests are not more than 1.5 times the normal limit and I don't have Gilbert's disease.I have had surgery for obesity, not including liposuction over a year ago.I am between 18 and 65 years old.I have kidney problems or my kidney function is low.
Research Study Groups:
This trial has the following groups:- Group 1: Part B: Multiple Ascending Dose Cohorts
- Group 2: Part A: Food Effect Cohort
- Group 3: Part A: Single Ascending Dose Cohorts
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Obesity Patient Testimony for trial: Trial Name: NCT05406115 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this trial restricted to persons over a certain age?
"Per the specified inclusion criteria, patients included in this trial are aged between 18 and 65. For those younger or older than that range, there exist 202 trials for children and 595 for seniors."
Answered by AI
What is the size of this research cohort?
"That is correct. According to information hosted on clinicaltrials.gov, enrollment is still open for this trial which was originally posted on July 26th 2022 and last updated in December 1st of the same year. 78 patients are needed from 4 different medical sites."
Answered by AI
What potential hazards have been linked to AMG 786 use?
"Due to the limited evidence available, AMG 786's safety score was a 1 as it is currently in its Phase 1 trial."
Answered by AI
Are there opportunities to join this research endeavor at present?
"This clinical trial is currently seeking volunteers, according to the official listing on clinicaltrials.gov. It was initially posted in late July 2022 and was updated last December 1st."
Answered by AI
Is it feasible for me to participate in this experiment?
"This clinical trial is onboarding 78 adults from 18 to 65 years old with obesity. In order to be eligible, patients must give informed consent and pass a medical evaluation. Furthermore, they should have had no menstrual cycles for at least 12 months if older than 55 or FSH levels above 40 IU/L otherwise; alternatively, having undergone hysterectomy or bilateral oophorectomy also suffices. Participants must conform to the body mass index requirements of between 18-25 kg/m2 in healthy individuals and 25-32kg/m2 in obese ones, while maintaining their diet and physical activity regimen - save for any"
Answered by AI
Who else is applying?
What state do they live in?
Florida
California
How old are they?
18 - 65
What site did they apply to?
Translational Clinical Research LLC
Other
Clinical Pharmacology of Miami, LLC
Orange County Research Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
2
0
Why did patients apply to this trial?
Fail in the past . Interested in getting paid tbh. It seems like there are a lot of amazing drugs for obesity ready to be researched!
PatientReceived 2+ prior treatments
I've tried several ways to lose weight since having my second child and I have not been successful in losing weight .
PatientReceived 1 prior treatment
What questions have other patients asked about this trial?
Can we do it remote? Are there any drugs that would exclude me from the trial?
PatientReceived 1 prior treatment
How long is the trial? What type of medication is given? Is there a placebo? What are the possible side effects? which ones are the most common? How does the drug work (explanation for a non-medical person) What are the common results from other patients?
PatientReceived 1 prior treatment
How responsive is this trial?
Average response time
- < 1 Day
Most responsive sites:
- Orange County Research Center: < 24 hours
Typically responds via
Phone Call
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger