ObesityPhase 1NCT05406115
Single and Multiple Ascending Dose Study to Evaluate AMG 786 in Healthy Participants and Participants With Obesity
A Phase 1 study testing AMG 786 in people with Obesity, run by Amgen at 3 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- AMG 786
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 65 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jul 2022to 21 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant has provided informed consent/assent prior to initiation of any study-specific activities/procedures
- Age 18 to 65 years at the time of signing the informed consent
- Female participants must be of non-childbearing potential (as described below)
- Postmenopausal is 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
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- History of hysterectomy; OR
- History of bilateral oophorectomy
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests, and Electrocardiograms (ECGs) on day -1 (Part A) and day -1 (Part B) and screening
- Body Mass Index must be between 18 and < 25 kg/m^2 for healthy participants and between ≥ 25 and ≤ 32.0 kg/m^2 for otherwise healthy participants with obesity
- Have a stable body weight (less than 5 kg self-reported change during the previous 8 weeks) prior to screening
- Willing to maintain current general diet and physical activity regimen, except for the physical activity in the 72 hours before each blood sample collection for the clinical laboratory analysis, which should not be strenuous
Who cannot join
- Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years
- History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dl (6.9 mmol/L) and/or HbA1c ≥ 6.5%
- Triglycerides ≥ 5.65 mmol/L (ie, 500 mg/dL) at screening
- Hepatic liver enzymes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin levels > 1.5 times the upper limit of normal (ULN) at screening. Participants with suspected or diagnosed Gilbert's disease will be excluded from the study.
- History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (APTT), International normalized ratio (INR) or platelet count outside of the laboratory's normal reference range unless interpreted as not clinically significant by the investigator in consultation with the medical monitor at screening.
- 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)
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- Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone (TSH) value outside normal range
- A corrected QT interval at screening of > 450 msec in males or > 470 msec in females or history of long QT syndrome
- History of coronary artery disease or congestive heart failure
- Participants with a history of renal impairment or renal disease and/or estimated glomerular filtration rate (eGFR) ≤ 60 mL/min/1.73 m^2
- Obesity induced by other endocrinologic disorders (eg, Cushing's Syndrome)
- Previous surgical treatment for obesity (excluding liposuction if performed > 1 year before trial entry)
- History of major depressive disorder
- History of other severe psychiatric disorders, eg, schizophrenia, bipolar disorder
- A patient health questionnaire-9 score of ≥ 10
- Participant has a history or evidence of suicidal ideation (severity of 3, 4 or 5) or any suicidal behavior based on an assessment with the Columbia suicide severity rating scale at screening
- Surgery scheduled for the trial duration period, except for minor surgical procedures, with consultation by the Amgen Medical Monitor
- 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
- Participant has systolic blood pressure ≥ 150 mm Hg or diastolic blood pressure ≥ 90 mm Hg at screening, and on day -1. For each visit, if the initial blood pressure is elevated, the reading may be repeated once at least 15 minutes later and the lower of the 2 readings may be used
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Translational Clinical Research LLC
Aventura, Florida, 33180
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
Orange County Research Center
Tustin, California, 92780
About this study
Official title: A Phase 1, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 786 in Healthy Subjects and Subjects With Obesity
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.
Read the detailed description
The 4th Multiple Ascending Dose cohort was not started.
- Conditions
- Obesity
- Being tested
- AMG 786, Placebo
- Keywords
- Obesity, AMG 786, Metabolic Indication
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AMG 786Drug
Oral tablet
PlaceboOther
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Part A: Single Ascending Dose Cohorts | Experimental | Participants in 4 cohorts will receive either AMG 786 or placebo in Single Ascending Doses. Receives: Drug: AMG 786; Other: Placebo |
| Part A: Food Effect Cohort | Experimental | 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. Receives: Drug: AMG 786; Other: Placebo |
| Part B: Multiple Ascending Dose Cohorts | Experimental | Participants in 4 cohorts will receive either AMG 786 or placebo in Multiple Ascending Doses. Receives: Drug: AMG 786; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Any clinically significant changes in vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs.
Measured: Day 1 through end of study (approximately 40 days)
Secondary outcomes (6)
Maximum Observed Concentration (Cmax) of AMG 786
Measured: Day 1 through end of study (approximately 40 days)
Time of Maximum Observed Concentration (Tmax) of AMG 786
Measured: Day 1 through end of study (approximately 40 days)
Area Under the Concentration-time Curve (AUC) of AMG 786
Measured: Day 1 through end of study (approximately 40 days)
Cmax of Metabolite M5
Measured: Day 1 through end of study (approximately 40 days)
Tmax of Metabolite M5
Measured: Day 1 through end of study (approximately 40 days)
AUC of Metabolite M5
Measured: Day 1 through end of study (approximately 40 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start26 Jul 2022
- Primary completion21 Aug 2023
- Study completion21 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05406115
- Sponsor's protocol ID
- 20210011
- Status last verified
- Oct 2025
- First submitted
- 1 Jun 2022
- Last updated
- 27 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-blind, Placebo Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AMG 786 in Healthy Subjects and Subjects With Obesity
- ClinicalTrials.gov ID
- NCT05406115
- Acronym / sponsor ID
- 20210011
- Conditions
- Obesity
- Keywords
- Obesity, AMG 786, Metabolic Indication
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 21 Aug 2023 (actual)
- Study completion
- 21 Aug 2023 (actual)
- First posted
- 6 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The 4th Multiple Ascending Dose cohort was not started.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part A: Single Ascending Dose Cohorts | Experimental | Drug: AMG 786, Other: PlaceboParticipants in 4 cohorts will receive either AMG 786 or placebo in Single Ascending Doses. |
| Part A: Food Effect Cohort | Experimental | Drug: AMG 786, Other: PlaceboParticipants 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. |
| Part B: Multiple Ascending Dose Cohorts | Experimental | Drug: AMG 786, Other: PlaceboParticipants in 4 cohorts will receive either AMG 786 or placebo in Multiple Ascending Doses. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Participant has provided informed consent/assent prior to initiation of any study-specific activities/procedures
- Age 18 to 65 years at the time of signing the informed consent
- Female participants must be of non-childbearing potential (as described below)
- 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
Key exclusion criteria (19 listed)
- Malignancy except non-melanoma skin cancers, cervical or breast ductal carcinoma in situ within the last 5 years
- History or clinical evidence of diabetes mellitus, including a fasting glucose ≥ 125 mg/dl (6.9 mmol/L) and/or HbA1c ≥ 6.5%
- Triglycerides ≥ 5.65 mmol/L (ie, 500 mg/dL) at screening
- Hepatic liver enzymes alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, or total bilirubin levels > 1.5 times the upper limit of normal (ULN) at screening. Participants with suspected or diagnosed Gilbert's disease will be excluded from the study.
- History or clinical evidence of bleeding diathesis or any coagulation disorder, including prothrombin time (PT), activated partial thromboplastin time (APTT), International normalized ratio (INR) or platelet count outside of the laboratory's normal reference range unless interpreted as not clinically significant by the investigator in consultation with the medical monitor at screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 786Oral tablet | Drug | Part A: Food Effect Cohort, Part A: Single Ascending Dose Cohorts, Part B: Multiple Ascending Dose Cohorts |
| PlaceboOral tablet | Other | Part A: Food Effect Cohort, Part A: Single Ascending Dose Cohorts, Part B: Multiple Ascending Dose Cohorts |
Primary outcome
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE)
Time frame: Day 1 through end of study (approximately 40 days)
Any clinically significant changes in vital signs, 12-lead electrocardiograms (ECGs) and clinical laboratory tests will be recorded as TEAEs.
6 secondary outcomes
Maximum Observed Concentration (Cmax) of AMG 786
Time frame: Day 1 through end of study (approximately 40 days)
Time of Maximum Observed Concentration (Tmax) of AMG 786
Time frame: Day 1 through end of study (approximately 40 days)
Area Under the Concentration-time Curve (AUC) of AMG 786
Time frame: Day 1 through end of study (approximately 40 days)
Cmax of Metabolite M5
Time frame: Day 1 through end of study (approximately 40 days)
Tmax of Metabolite M5
Time frame: Day 1 through end of study (approximately 40 days)
AUC of Metabolite M5
Time frame: Day 1 through end of study (approximately 40 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AMG 786 in people with Obesity, run by Amgen at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants who Experience a Treatment-emergent Adverse Event (TEAE) (time frame: Day 1 through end of study (approximately 40 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025; AzTrials last refreshed its copy on 29 Oct 2026.