ObesityPhase 1NCT04199351

Single and Multiple Ascending Dose Study of AMG 171 in Subjects With Obesity

A Phase 1 study testing AMG 171 in people with Obesity, run by Amgen at 3 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects 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 171
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 3 sitesUnited States
Study dates: 13 Dec 2019to 10 Sep 2021
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

Males and females with ages between 18 and 65 years old, inclusive
Except for obesity, otherwise healthy
Body mass index (BMI) greater than or equal to 30.0 kg/m2 and less than or equal to 40.0 kg/m2 at screening
Other Inclusion criteria may apply

Who cannot join

Currently receiving treatment in another investigational device or drug study
Women of childbearing potential
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
Other Exclusion criteria may apply

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Anaheim Clinical Trials
Anaheim, California, 92801
Clinical Pharmacology of Miami, LLC
Miami, Florida, 33014
Orange County Research Center
Tustin, California, 92780

Other trials in United States

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 171 in Subjects With Obesity

To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity

Conditions: Obesity
Being tested: AMG 171, Placebo
Keywords: Obesity
Medical subject headings: Obesity

What participants receive

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

AMG 171Drug
2 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A; 1 cohort of 8 subjects 3:1 ratio in Part B; and 24 subjects enrolled into 1 of 3 cohorts with 8 subjects randomized to receive 2 to 3 consecutive doses (titration) 3:1 ratio in Part C.
PlaceboDrug
AMG 171 placebo

Study groups in NCT04199351
Study group	Role	What they receive
Part A	Experimental	AMG 171 or placebo, 2 SAD cohorts Receives: Drug: AMG 171; Drug: Placebo
Part B	Experimental	AMG 171 or placebo, 1 MAD cohort Receives: Drug: AMG 171; Drug: Placebo
Part C	Experimental	AMG 171 or placebo, 3 titration cohorts Receives: Drug: AMG 171; Drug: Placebo

What is being measured

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

Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. A serious AE (SAE) was an AE meeting at least 1 of the following serious criteria: fatal, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability; congenital anomaly/birth defect; other medically important serious event. Clinically significant changes from baseline in laboratory safety tests, vital sign assessments, and 12-lead electrocardiogram assessments were included as TEAEs.
Measured: From first dose of IP to end of study, up to Day 207

Secondary outcomes (8)

Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of pharmacokinetic (PK) parameters. Concentrations below the lower limit of quantification (LLOQ) (50.0 ng/mL) were set to zero before data analysis.
Measured: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
Cmax for AMG 171: MAD Cohorts 2 - 5
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Measured: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Measured: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
Tmax for AMG 171: MAD Cohorts 2 - 5
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Measured: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Measured: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Measured: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113
AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5
Serum concentrations of AMG 171 were determined using a validated assay. Noncompartmental analysis was performed for estimation of PK parameters. Concentrations below the LLOQ (50.0 ng/mL) were set to zero before data analysis.
Measured: Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
Number of Participants With Anti-AMG 171 Antibodies
Serum samples were tested for binding and neutralizing antibodies against human Growth Differentiation Factor 15. Participants with transiently positive for binding or neutralizing antibodies had a negative result at the participant's last time point tested.
bAb = binding antibody; nAb = neutralizing antibody; +ve = positive; -ve = negative; BL = baseline.
Measured: Cohorts 1 and 1b: Day 1 pre-dose, Days 15, 29, 120; Cohort 2: Days 1, 29, 57 pre-dose, Days 15, 85, 207; Cohort 3: Days 1, 15 pre-dose, Days 29, 57, 85; Cohort 4: Days 1, 15, 29 pre-dose, Days 43, 85, 113; Cohort 5: Days 1, 8 pre-dose, Days 29, 57, 85

Timeline

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

13 Dec 201910 Sep 2021

First posted13 Dec 2019
Study start13 Dec 2019
Primary completion10 Sep 2021
Study completion10 Sep 2021

Why it stopped: Amgen determined the totality of the data does not support continuation of AMG 171 development program for treatment of Obesity. No safety concerns identified.

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: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04199351
Sponsor's protocol ID: 20180224
Status last verified: Apr 2024
First submitted: 12 Dec 2019
Last updated: 19 Sep 2024
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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Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2024. 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 171 in Subjects With Obesity
ClinicalTrials.gov ID: NCT04199351
Acronym / sponsor ID: 20180224
Conditions: Obesity
Keywords: Obesity
Phase: Phase 1
Study type: Interventional
Recruitment status: TerminatedReason stopped: Amgen determined the totality of the data does not support continuation of AMG 171 development program for treatment of Obesity. No safety concerns identified.
Enrolment: 60 participants (actual)
Lead sponsor: AmgenIndustry (pharma, biotech, devices)
Study start: 13 Dec 2019 (actual)
Primary completion: 10 Sep 2021 (actual)
Study completion: 10 Sep 2021 (actual)
First posted: 13 Dec 2019 (actual)
Results: Posted 19 Sep 2024

Clinical summary

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

To assess the safety and tolerability of AMG 171 as single or multiple doses in subjects with obesity

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Sequential
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Part A	Experimental	Drug: AMG 171, Drug: PlaceboAMG 171 or placebo, 2 SAD cohorts
Part B	Experimental	Drug: AMG 171, Drug: PlaceboAMG 171 or placebo, 1 MAD cohort
Part C	Experimental	Drug: AMG 171, Drug: PlaceboAMG 171 or placebo, 3 titration cohorts

Who may qualify

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

Key inclusion criteria (4 listed)

Males and females with ages between 18 and 65 years old, inclusive
Except for obesity, otherwise healthy
Body mass index (BMI) greater than or equal to 30.0 kg/m2 and less than or equal to 40.0 kg/m2 at screening
Other Inclusion criteria may apply

Key exclusion criteria (4 listed)

Currently receiving treatment in another investigational device or drug study
Women of childbearing potential
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
Other Exclusion criteria may apply

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 1712 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A; 1 cohort of 8 subjects 3:1 ratio in Part B; and 24 subjects enrolled into 1 of 3 cohorts with 8 subjects randomized to receive 2 to 3 consecutive doses (titration) 3:1 ratio in Part C.	Drug	Part A, Part B, Part C
PlaceboAMG 171 placebo	Drug	Part A, Part B, Part C

Primary outcome

Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)
Time frame: From first dose of IP to end of study, up to Day 207
An adverse event (AE) was any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with study treatment. A serious AE (SAE) was an AE meeting at least 1 of the following serious criteria: fatal, life-threatening, required in-patient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability; congenital anomaly/birth defect; other medically important serious event. Clinically significant changes from baseline in laboratory safety tests, vital sign assessments, and 12-lead electrocardiogram assessments were included as TEAEs.

8 secondary outcomes

Maximum Observed Serum Concentration (Cmax) for AMG 171: SAD Cohorts 1 and 1b
Time frame: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
Cmax for AMG 171: MAD Cohorts 2 - 5
Time frame: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
Time of Cmax (Tmax) for AMG 171: SAD Cohorts 1 and 1b
Time frame: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
Tmax for AMG 171: MAD Cohorts 2 - 5
Time frame: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113; Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Infinity (AUCinf) for AMG 171: SAD Cohorts 1 and 1b
Time frame: Cohorts 1 and 1b: pre-dose Day 1; 1, 2, 4, and 8 hours post-dose Day 1, Days 2 up to Day 120
AUC From Time 0 to 14 Days (AUC0-14) for AMG 171: MAD Cohorts 2 - 4
Time frame: Cohort 2: pre-dose Days 1, 15, 29, 43, 57, 71; post-dose Days 5 up to 207; Cohort 3: pre-dose Days 1, 15; post-dose Days 2 up to 85; Cohort 4: pre-dose Days 1, 15, 29; post-dose Days 2 up to 113
AUC From Time 0 to 7 Days (AUC0-7) for AMG 171: MAD Cohort 5
Time frame: Cohort 5: pre-dose Days 1, 8; post-dose Days 2 up to 85
Number of Participants With Anti-AMG 171 Antibodies
Time frame: Cohorts 1 and 1b: Day 1 pre-dose, Days 15, 29, 120; Cohort 2: Days 1, 29, 57 pre-dose, Days 15, 85, 207; Cohort 3: Days 1, 15 pre-dose, Days 29, 57, 85; Cohort 4: Days 1, 15, 29 pre-dose, Days 43, 85, 113; Cohort 5: Days 1, 8 pre-dose, Days 29, 57, 85

Results and safety

Results posted to the registry on 19 Sep 2024, 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 (Cohorts 1 and 1b)	4	4
Cohort 1 (Part A): AMG 171 Dose A	7	6
Cohort 1b (Part A): AMG 171 Dose B	6	5
Placebo (Cohort 4 Replaced)	2	0
Placebo (Cohorts 2-5)	8	7
Cohort 2 (Part B): AMG 171 Dose A Q2W	7	2
Cohort 3 (Part C): AMG 171 Dose A/Dose B	8	6
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C	6	6
Cohort 5 (Part C): AMG 171 Dose A/Dose B	6	3
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C	6	0

Primary outcome: Number of Participants Who Experienced Treatment-Emergent Adverse Events (TEAEs)

Time frame: From first dose of IP to end of study, up to Day 207. Count of participants. Unit: Participants

Measure	Cohort 1 (Part A): AMG 171 Dose A n = 7	Cohort 1b (Part A): AMG 171 Dose B n = 6	Placebo (Cohorts 2-5) n = 8	Cohort 2 (Part B): AMG 171 Dose A Q2W n = 7	Cohort 3 (Part C): AMG 171 Dose A/Dose B n = 8	Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C n = 6	Cohort 5 (Part C): AMG 171 Dose A/Dose B n = 6	Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C n = 6
Any TEAEs	5	6	3	7	5	5	5	5
Any SAE	0	0	0	0	0	0	0	0
Any TEAE leading to IP discontinuation	0	0	0	0	0	0	0	0

Population analysed: The safety analysis set included all participants who received at least 1 dose of IP.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was collected from informed consent to end of study, up to approximately 235 days. SAEs and other AEs were collected from first dose of IP to end of study, up to Day 207.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo (Cohort 1 and 1b)	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Cohort 1 (Part A): AMG 171 Dose A	0 of 7 (0%)	5 of 7 (71.4%)	0 of 7
Cohort 1b (Part A): AMG 171 Dose B	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Placebo (Cohort 4 Replaced)	0 of 2 (0%)	0 of 2 (0%)	0 of 2
Placebo (Cohorts 2-5)	0 of 8 (0%)	3 of 8 (37.5%)	0 of 8
Cohort 2 (Part B): AMG 171 Dose A Q2W	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Cohort 3 (Part C): AMG 171 Dose A/Dose B	0 of 8 (0%)	5 of 8 (62.5%)	0 of 8
Cohort 4 (Part C): AMG 171 Dose A/Dose B/Dose C	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 5 (Part C): AMG 171 Dose A/Dose B	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Cohort 4 Replaced (Part C): AMG 171 Dose A/Dose B/Dose C	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
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

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 171 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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 19 Sep 2024. 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?

Yes. Results are posted in the registry (first posted 19 Sep 2024). 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 Who Experienced Treatment-Emergent Adverse Events (TEAEs) (time frame: From first dose of IP to end of study, up to Day 207). 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 NCT04199351.

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 19 Sep 2024.