ObesityPhase 1NCT03757130

Multiple Ascending Dose Study of AMG 598 in Adults With Obesity

A Phase 1 study testing AMG 598 and Liraglutide in people with Obesity, run by Amgen at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The main objective of this study is to assess the safety and tolerability of multiple doses of AMG 598 administered alone or in combination with liraglutide in adults with obesity. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Obesity
What is being tested?: AMG 598 and Liraglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 50 participants
Where: 4 sitesUnited States
Study dates: 26 Nov 2018to 16 Dec 2019
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
No healthy volunteers
Adult, Older adult

Who may be able to join

Men and women with ages between 18 and 65 years old, inclusive, at time of signing consent
Body mass index (BMI) between greater than or equal to 30.0 kg/m^2 and less than or equal to 40.0 kg/m^2 at screening
Except for obesity, otherwise healthy or medically stable per protocol
Have a stable body weight defined as less than 5 kg self-reported change during the previous 8 weeks prior to screening
Other Inclusion criteria may apply
Stable on liraglutide, depending on cohort

Who cannot join

History or clinical evidence of diabetes
Inadequate organ function at screening
Currently receiving treatment in another investigational device or drug study
Women who are pregnant/lactating/breastfeeding or who plan to become pregnant/breastfeed while on study through 5 months after receiving the last dose of investigational product
History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion
A family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2; a personal history of non-familial medullary thyroid carcinoma; confirmed chronic pancreatitis or idiopathic acute pancreatitis, or gallbladder disease (ie, cholelithiasis or cholecystitis) not treated with cholecystectomy, for cohorts receiving liraglutide
History of major depressive disorder
Other Exclusion criteria may apply

Trial locations and contacts

4 sites in 1 country.

United States4 sites

William D Summers MD LLC
Birmingham, Alabama, 35235
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
QPS Miami Research Associates
South Miami, Florida, 33143
Orange County Research Center
Tustin, California, 92780

Other trials in United States

About this study

Official title: A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 598 in Subjects With Obesity

The main objective of this study is to assess the safety and tolerability of multiple doses of AMG 598 administered alone or in combination with liraglutide in adults with obesity.

Conditions: Obesity
Being tested: AMG 598, Placebo, Liraglutide
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AMG 598Drug
AMG 598 administered by subcutaneous injection
PlaceboDrug
Placebo matching to AMG 598 administered by subcutaneous injection
LiraglutideDrug
Also called Saxenda®
Liraglutide administered by subcutaneous injection. The starting dose is 0.6 mg/day, and increased by 0.6 mg/day dose increment every 7 days, up to the full dosage of 3.0 mg/day by week 5.

Study groups in NCT03757130
Study group	Role	What they receive
Placebo	Placebo comparator	Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. Receives: Drug: Placebo
Placebo + Liraglutide	Active comparator	Participants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5. Receives: Drug: Placebo; Drug: Liraglutide
AMG 598 70 mg	Experimental	Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses. Receives: Drug: AMG 598
AMG 598 70 mg + Liraglutide	Experimental	Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5. Receives: Drug: AMG 598; Drug: Liraglutide
AMG 598 210 mg	Experimental	Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. Receives: Drug: AMG 598
AMG 598 210 mg + Liraglutide	Experimental	Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5. Receives: Drug: AMG 598; Drug: Liraglutide
AMG 598 420 mg	Experimental	Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses. Receives: Drug: AMG 598
AMG 598 420 mg + Liraglutide	Experimental	Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5. Receives: Drug: AMG 598; Drug: Liraglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Treatment-emergent Adverse Events
The investigator assessed the severity of each adverse event reported during the study. The assessment was based on the Amgen Standard Grading Scale:
Mild: Aware of sign or symptom, but easily tolerated. Moderate: Discomfort enough to cause interference with usual activity. Severe: Incapacitating with inability to work or do usual activity.
A Serious adverse event is defined as any untoward medical occurrence that, met at least 1 of the following serious criteria
- Death;
- Was life-threatening;
- Required in-patient hospitalization or prolongation of existing hospitalization;
- Resulted in persistent or significant disability/incapacity;
- Was a congenital anomaly/birth defect;
- Other medically important serious event.
The investigator also assessed whether each adverse event was related to study drug administration based on clinical judgement.
Measured: 207 days
Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
TEAEs due to laboratory, electrocardiogram (ECG) and vital sign findings include any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or electrocardiogram, or vital signs measurements, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator (ie, not related to progression of underlying disease).
Measured: 207 days

Secondary outcomes (9)

Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Measured: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Measured: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Measured: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Area Under the Concentration-time Curve From Time 0 to 28 Days (AUC0-28) for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Measured: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Measured: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of AMG 598 After Subcutaneous Injection on Day 57
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Measured: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Accumulation ratio for Cmax = Day 57 Cmax / Day 1 Cmax.
Measured: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
The accumulation ratio for AUC0-28 = Day 57 AUC0-28 / Day 1 AUC0-28.
Measured: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57
Serum concentrations of AMG 598 were determined using a validated electrochemiluminescence-based method. The lower limit of quantitation was 50.0 ng/mL.
Measured: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Nov 201816 Dec 2019

First posted28 Nov 2018
Study start26 Nov 2018
Primary completion16 Dec 2019
Study completion16 Dec 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03757130
Sponsor's protocol ID: 20170139
Status last verified: Nov 2022
First submitted: 27 Nov 2018
Last updated: 14 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 598 in Subjects With Obesity
ClinicalTrials.gov ID: NCT03757130
Acronym / sponsor ID: 20170139
Conditions: Obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 26 Nov 2018 (actual)
Primary completion: 16 Dec 2019 (actual)
Study completion: 16 Dec 2019 (actual)
First posted: 28 Nov 2018 (actual)
Results: Posted 14 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The main objective of this study is to assess the safety and tolerability of multiple doses of AMG 598 administered alone or in combination with liraglutide in adults with obesity.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboParticipants received placebo subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
Placebo + Liraglutide	Active comparator	Drug: Placebo, Drug: LiraglutideParticipants received placebo subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
AMG 598 70 mg	Experimental	Drug: AMG 598Participants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks (Q4W) for a total of 3 doses.
AMG 598 70 mg + Liraglutide	Experimental	Drug: AMG 598, Drug: LiraglutideParticipants received 70 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
AMG 598 210 mg	Experimental	Drug: AMG 598Participants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
AMG 598 210 mg + Liraglutide	Experimental	Drug: AMG 598, Drug: LiraglutideParticipants received 210 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.
AMG 598 420 mg	Experimental	Drug: AMG 598Participants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses.
AMG 598 420 mg + Liraglutide	Experimental	Drug: AMG 598, Drug: LiraglutideParticipants received 420 mg AMG 598 by subcutaneous injection once every 4 weeks for a total of 3 doses in addition to liraglutide administered by subcutaneous injection once a day for 12 weeks. The starting dose of liraglutide was 0.6 mg/day, increasing in increments of 0.6 mg/day every 7 days to reach the full dosage of 3 mg/day by week 5.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Men and women with ages between 18 and 65 years old, inclusive, at time of signing consent
Body mass index (BMI) between greater than or equal to 30.0 kg/m^2 and less than or equal to 40.0 kg/m^2 at screening
Except for obesity, otherwise healthy or medically stable per protocol
Have a stable body weight defined as less than 5 kg self-reported change during the previous 8 weeks prior to screening
Other Inclusion criteria may apply

Key exclusion criteria (8 listed)

History or clinical evidence of diabetes
Inadequate organ function at screening
Currently receiving treatment in another investigational device or drug study
Women who are pregnant/lactating/breastfeeding or who plan to become pregnant/breastfeed while on study through 5 months after receiving the last dose of investigational product
History or evidence of a clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion

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 598AMG 598 administered by subcutaneous injection	Drug	AMG 598 210 mg, AMG 598 210 mg + Liraglutide, AMG 598 420 mg, AMG 598 420 mg + Liraglutide, AMG 598 70 mg, AMG 598 70 mg + Liraglutide
PlaceboPlacebo matching to AMG 598 administered by subcutaneous injection	Drug	Placebo, Placebo + Liraglutide
LiraglutideAlso: Saxenda®Liraglutide administered by subcutaneous injection. The starting dose is 0.6 mg/day, and increased by 0.6 mg/day dose increment every 7 days, up to the full dosage of 3.0 mg/day by week 5.	Drug	AMG 598 210 mg + Liraglutide, AMG 598 420 mg + Liraglutide, AMG 598 70 mg + Liraglutide, Placebo + Liraglutide

Primary outcome

Number of Participants With Treatment-emergent Adverse Events
Time frame: 207 days
The investigator assessed the severity of each adverse event reported during the study. The assessment was based on the Amgen Standard Grading Scale: Mild: Aware of sign or symptom, but easily tolerated. Moderate: Discomfort enough to cause interference with usual activity. Severe: Incapacitating with inability to work or do usual activity. A Serious adverse event is defined as any untoward medical occurrence that, met at least 1 of the following serious criteria * Death; * Was life-threatening; * Required in-patient hospitalization or prolongation of existing hospitalization; * Resulted in persistent or significant disability/incapacity; * Was a congenital anomaly/birth defect; * Other medically important serious event. The investigator also assessed whether each adverse event was related to study drug administration based on clinical judgement.
Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings
Time frame: 207 days
TEAEs due to laboratory, electrocardiogram (ECG) and vital sign findings include any abnormal laboratory test results (hematology, clinical chemistry, or urinalysis) or electrocardiogram, or vital signs measurements, including those that worsened from baseline, that were considered clinically significant in the medical and scientific judgment of the investigator (ie, not related to progression of underlying disease).

9 secondary outcomes

Maximum Observed Concentration (Cmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Time to Maximum Observed Concentration (Tmax) of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Dose-normalized Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Area Under the Concentration-time Curve From Time 0 to 28 Days (AUC0-28) for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
Dose-normalized AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
Area Under the Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUClast) of AMG 598 After Subcutaneous Injection on Day 57
Time frame: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Accumulation Ratio (AR) for Cmax of AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207
Accumulation Ratio of AUC0-28 for AMG 598 After Subcutaneous Injection on Day 1 and Day 57
Time frame: Day 1, predose, and days 6, 8, 15, 22, and 29; Day 57 predose and days 62, 64, 71, and 85
Terminal Half-life (T1/2,z) of AMG 598 After Subcutaneous Injection on Day 57
Time frame: Day 57 predose and days 62, 64, 71, 85, 99, 113, 127, 169, and 207

Results and safety

Results posted to the registry on 14 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	6	6
Placebo + Liraglutide	6	6
AMG 598 70 mg	6	6
AMG 598 70 mg + Liraglutide	8	7
AMG 598 210 mg	6	6
AMG 598 210 mg + Liraglutide	6	6
AMG 598 420 mg	6	5
AMG 598 420 mg + Liraglutide	6	5

Primary outcome: Number of Participants With Treatment-emergent Adverse Events

Time frame: 207 days. Count of participants. Unit: Participants

Measure	Placebo n = 6	Placebo + Liraglutide n = 6	AMG 598 70 mg n = 6	AMG 598 70 mg + Liraglutide n = 8	AMG 598 210 mg n = 6	AMG 598 210 mg + Liraglutide n = 6	AMG 598 420 mg + Liraglutide n = 6
All treatment-emergent adverse events (TEAEs)	1	6	4	7	5	6	4
Mild TEAEs	1	6	4	7	5	6	4
Moderate TEAEs	0	1	0	2	0	0	1
Severe TEAEs	0	0	0	0	0	0	0
Serious TEAEs	0	0	0	0	0	0	0
TEAE leading to discontinuation of AMG 598	0	0	0	0	0	0	1
TEAE leading to discontinuation of liraglutide	0	1	0	1	0	0	2
Life-threatening TEAEs	0	0	0	0	0	0	0

Population analysed: All participants who received at least 1 dose of study drug (AMG 598 or placebo) on day 1.

Primary outcome: Number of Participants With TEAEs Due to Laboratory, Electrocardiogram, and Vital Sign Findings

Time frame: 207 days. Count of participants. Unit: Participants

Measure	Placebo + Liraglutide n = 6	AMG 598 70 mg n = 6	AMG 598 70 mg + Liraglutide n = 8	AMG 598 210 mg n = 6	AMG 598 210 mg + Liraglutide n = 6	AMG 598 420 mg + Liraglutide n = 6
Blood creatine phosphokinase increased	0	0	0	1	0	0
Electrocardiogram T wave abnormal	0	0	0	0	0	1
Hepatic enzyme increased	0	0	0	0	0	1
Lipase increased	1	0	3	0	1	1
Hypertension	0	1	0	0	0	0

Population analysed: All participants who received at least 1 dose of study drug (AMG 598 or placebo) on day 1.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first dose of AMG 598/placebo through the end of study; 207 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 6 (0%)	1 of 6 (16.7%)	0 of 6
Placebo + Liraglutide	0 of 6 (0%)	6 of 6 (100%)	0 of 6
AMG 598 70 mg	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
AMG 598 70 mg + Liraglutide	0 of 8 (0%)	7 of 8 (87.5%)	0 of 8
AMG 598 210 mg	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
AMG 598 210 mg + Liraglutide	0 of 6 (0%)	6 of 6 (100%)	0 of 6
AMG 598 420 mg	0 of 6 (0%)	0 of 6 (0%)	0 of 6
AMG 598 420 mg + Liraglutide	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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

4 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 598 and Liraglutide in people with Obesity, run by Amgen at 4 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 6 inclusion and 8 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 14 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 14 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 With Treatment-emergent Adverse Events (time frame: 207 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03757130.

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 14 Sep 2023.