HealthyPhase 1NCT02759107

A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

A Phase 1 study testing Tirzepatide and Dulaglutide in people with Healthy and Type 2 Diabetes Mellitus (T2DM), run by Eli Lilly and Company at 2 sites in 2 countries.

Completed

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

Official record

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Trial summary

The main purposes of this study are to determine: The safety of tirzepatide and any side effects that might be associated with it. How much tirzepatide gets into the bloodstream and how long it takes the body to get rid of it. How tirzepatide affects the levels of blood sugar. This study includes 3 parts (A, B and C). Read more about this study

Who is it for?: Ages 21 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Type 2 Diabetes Mellitus (T2DM)
What is being tested?: Tirzepatide and Dulaglutide
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 142 participants
Where: 2 sitesin 2 countries
Study dates: 11 May 2016to 26 Jun 2017
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 21 to 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy participants (Parts A and B) and participants with T2DM diagnosed at least 1 year before enrollment (Part C)
Have a screening body mass index (BMI) of greater than 18.5 and less than or equal to 40.0 kilograms per meter squared (kg/m²), inclusive
Participants with T2DM (Part C only): have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin for at least 30 days or sulfonylureas). Participants receiving sulfonylureas may participate only if this treatment is stopped for at least 6 weeks before dosing with study drug

Who cannot join

Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (greater than 2-fold the upper limit of normal [ULN]) or gastrointestinal (GI) disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase (DPP)-IV inhibitors
Participants with T2DM (Part C only)
Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms
All Study Participants (Parts B and C only)
have known allergies to tirzepatide, GLP-1 analogs, or related compounds, or acetaminophen

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

Miami Research Associates
South Miami, Florida, 33143

Other trials in United States

Singapore1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Singapore, 117597

Other trials in Singapore

About this study

Official title: A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176 and Multiple Doses in Patients With Type 2 Diabetes Mellitus

The main purposes of this study are to determine:

The safety of tirzepatide and any side effects that might be associated with it.
How much tirzepatide gets into the bloodstream and how long it takes the body to get rid of it.
How tirzepatide affects the levels of blood sugar.

This study includes 3 parts (A, B and C). Part A involves a single dose of tirzepatide taken as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in duration, including screening. Parts B and C involve 4 doses of tirzepatide taken once weekly (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in duration, including screening. Each participant will enroll in only one part.

This study is for research purposes only, and is not intended to treat any medical condition.

Conditions: Healthy, Type 2 Diabetes Mellitus (T2DM)
Being tested: Tirzepatide, Placebo, Dulaglutide
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

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

TirzepatideDrug
Also called LY3298176
Administered SC
PlaceboDrug
Administered SC
DulaglutideDrug
Also called Trulicity®
Administered SC

Study groups in NCT02759107
Study group	Role	What they receive
Tirzepatide (Part A)	Experimental	Participants received escalating single doses of either 0.25 milligram (mg) or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide by subcutaneous injection. Receives: Drug: Tirzepatide
Placebo (Part A)	Placebo comparator	Participants received single dose of placebo by subcutaneous injection. Receives: Drug: Placebo
Tirzepatide (Part B)	Experimental	Participants received fixed doses of either 0.5mg or 1.5mg or 4.5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg, 5mg, 8mg and 10mg Tirzepatide once weekly for four weeks by subcutaneous injection. Receives: Drug: Tirzepatide
Placebo (Part B)	Placebo comparator	Participants received placebo once weekly for four weeks by subcutaneous injection. Receives: Drug: Placebo
Dulaglutide (Part B)	Active comparator	Participants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection. Receives: Drug: Dulaglutide
Tirzepatide (Part C)	Experimental	Participants received fixed doses of either 0.5mg or 5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection Receives: Drug: Tirzepatide
Placebo (Part C)	Placebo comparator	Participants received placebo once weekly for four weeks by subcutaneous injection. Receives: Drug: Placebo

What is being measured

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

Number of Participants With One or More Serious Adverse Event(s) (SAEs)
Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module
Measured: Baseline through Day 43 (Part A) and Day 57 (Part B and C)

Secondary outcomes (5)

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A.
Area under the concentration versus time curve from zero to infinity (AUC [0-∞]) of Tirzepatide in Part A.
Measured: Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B
Area under the concentration versus time curve during 1 dosing interval (AUC [0-τ]) of Tirzepatide in Part B. τ equals 168 hours.
Measured: Predose, 8hours(h), 24h,48h,72h,168h postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C
Area under the concentration versus time curve during 1 dosing interval (AUC [0-τ]) of Tirzepatide in Part C. τ equals 168 hours.
Measured: Predose, 8hours(h), 24h,48h,72h,168h postdose
Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C)
PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC[0-2h]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).
Measured: Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2
Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C)
PD: Glucose area under the concentration versus time curve from time 0 to 2 hours (AUC[0-2h]) in Part C. Ratio to Baseline (Day -1) AUC (0-2h).
Measured: Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23

Timeline

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

11 May 201626 Jun 2017

First posted3 May 2016 (estimated)
Study start11 May 2016
Primary completion26 Jun 2017
Study completion26 Jun 2017

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe 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: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 142 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02759107
Sponsor's protocol ID: 16119
Other IDs: I8F-MC-GPGA
Status last verified: Apr 2023
First submitted: 29 Apr 2016
Last updated: 16 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Publications

Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D'Alessio DA, Haupt A. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Mol Metab. 2018 Dec;18:3-14. doi: 10.1016/j.molmet.2018.09.009. Epub 2018 Oct 3.
PubMed 30473097

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?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single- and Multiple-Ascending Dose Study in Healthy Subjects to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3298176 and Multiple Doses in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02759107
Acronym / sponsor ID: 16119
Conditions: Healthy, Type 2 Diabetes Mellitus (T2DM)
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 142 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Study start: 11 May 2016 (actual)
Primary completion: 26 Jun 2017 (actual)
Study completion: 26 Jun 2017 (actual)
First posted: 3 May 2016 (estimated)
Results: Posted 16 Jan 2024

Clinical summary

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

The main purposes of this study are to determine:

The safety of tirzepatide and any side effects that might be associated with it.
How much tirzepatide gets into the bloodstream and how long it takes the body to get rid of it.
How tirzepatide affects the levels of blood sugar.

This study is for research purposes only, and is not intended to treat any medical condition.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 7

Arm	Type	Receives
Tirzepatide (Part A)	Experimental	Drug: TirzepatideParticipants received escalating single doses of either 0.25 milligram (mg) or 0.5mg or 1mg, or 2.5mg or 5mg or 8mg Tirzepatide by subcutaneous injection.
Placebo (Part A)	Placebo comparator	Drug: PlaceboParticipants received single dose of placebo by subcutaneous injection.
Tirzepatide (Part B)	Experimental	Drug: TirzepatideParticipants received fixed doses of either 0.5mg or 1.5mg or 4.5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg, 5mg, 8mg and 10mg Tirzepatide once weekly for four weeks by subcutaneous injection.
Placebo (Part B)	Placebo comparator	Drug: PlaceboParticipants received placebo once weekly for four weeks by subcutaneous injection.
Dulaglutide (Part B)	Active comparator	Drug: DulaglutideParticipants received 1.5mg Dulaglutide once weekly for four weeks by subcutaneous injection.
Tirzepatide (Part C)	Experimental	Drug: TirzepatideParticipants received fixed doses of either 0.5mg or 5mg Tirzepatide once weekly for four weeks or titrated doses of 5mg,5mg,10mg,10mg or 5mg,5mg,10mg,15mg Tirzepatide once weekly for four weeks by subcutaneous injection
Placebo (Part C)	Placebo comparator	Drug: PlaceboParticipants received placebo once weekly for four weeks by subcutaneous injection.

Who may qualify

Ages: 21 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Healthy participants (Parts A and B) and participants with T2DM diagnosed at least 1 year before enrollment (Part C)
Have a screening body mass index (BMI) of greater than 18.5 and less than or equal to 40.0 kilograms per meter squared (kg/m²), inclusive
Participants with T2DM (Part C only): have T2DM controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (metformin for at least 30 days or sulfonylureas). Participants receiving sulfonylureas may participate only if this treatment is stopped for at least 6 weeks before dosing with study drug

Key exclusion criteria (7 listed)

Have known allergies to tirzepatide, glucagon-like peptide (GLP)-1 analogs, or related compounds
Have an abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study
Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase (greater than 2-fold the upper limit of normal [ULN]) or gastrointestinal (GI) disorder (for example, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (for example, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase (DPP)-IV inhibitors
Participants with T2DM (Part C only)
Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

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
TirzepatideAlso: LY3298176Administered SC	Drug	Tirzepatide (Part A), Tirzepatide (Part B), Tirzepatide (Part C)
PlaceboAdministered SC	Drug	Placebo (Part A), Placebo (Part B), Placebo (Part C)
DulaglutideAlso: Trulicity®Administered SC	Drug	Dulaglutide (Part B)

Primary outcome

Number of Participants With One or More Serious Adverse Event(s) (SAEs)
Time frame: Baseline through Day 43 (Part A) and Day 57 (Part B and C)
Number of participants with one or more SAEs considered by the investigator to be related to study drug administration. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, were reported in the Reported Adverse Events module

5 secondary outcomes

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part A.
Time frame: Predose, 8hours(h), 24h,48h,72h,96h,120h,168h,336h postdose, day 29, day 43
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part B
Time frame: Predose, 8hours(h), 24h,48h,72h,168h postdose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide in Part C
Time frame: Predose, 8hours(h), 24h,48h,72h,168h postdose
Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 2 to Baseline (Part C)
Time frame: Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 2
Pharmacodynamics (PD): Ratio of AUC of Glucose on Day 23 to Baseline (Part C)
Time frame: Pre-glucose dose, 0.5, 1, 1.5, 2 hours post-glucose dose on Day -1 and Day 23

Results and safety

Results posted to the registry on 16 Jan 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
Part A Placebo	14	14
Part A 0.25 mg Tirzepatide	6	6
Part A 0.5mg Tirzepatide	12	12
Part A 1mg Tirzepatide	5	5
Part A 2.5mg Tirzepatide	6	6
Part A 5mg Tirzepatide	6	6
Part A 8mg Tirzepatide	7	7
Part B Placebo	4	4
Part B 1.5mg Dulaglutide	4	4
Part B 0.5mg Tirzepatide	6	5
Part B 1.5mg Tirzepatide	6	6
Part B 4.5mg Tirzepatide	6	6
Part B 5, 5, 8,10mg Tirzepatide	7	5
Part C Placebo	11	11
Part C 0.5mg Tirzepatide	9	9
Part C 5mg Tirzepatide	9	8
Part C 5, 5, 10,10mg Tirzepatide	12	12
Part C 5, 5, 10,15mg Tirzepatide	12	10

Primary outcome: Number of Participants With One or More Serious Adverse Event(s) (SAEs)

Time frame: Baseline through Day 43 (Part A) and Day 57 (Part B and C). Number. Unit: Participants

Measure	Tirzepatide (Part A) n = 42	Placebo (Part A) n = 14	Tirzepatide (Part B) n = 25	Placebo (Part B) n = 4	Dulaglutide (Part B) n = 4	Tirzepatide (Part C) n = 42	Placebo (Part C) n = 11
Value	0	0	0	0	1	0	0

Population analysed: All randomized participants who received at least one dose of study drug.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to end of study (Up to 57 days). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part A - Placebo	0 of 14 (0%)	7 of 14 (50%)	0 of 14
Part A - 0.25mg Tirzepatide	0 of 6 (0%)	4 of 6 (66.7%)	0 of 6
Part A - 0.5mg Tirzepatide	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Part A - 1mg Tirzepatide	0 of 5 (0%)	3 of 5 (60%)	0 of 5
Part A - 2.5mg Tirzepatide	0 of 6 (0%)	2 of 6 (33.3%)	0 of 6
Part A - 5mg Tirzepatide	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part A - 8mg Tirzepatide	0 of 7 (0%)	7 of 7 (100%)	0 of 7
Part B - Placebo	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Part B - 1.5mg Dulaglutide	1 of 4 (25%)	3 of 4 (75%)	0 of 4
Part B - 0.5mg Tirzepatide	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part B - 1.5mg Tirzepatide	0 of 6 (0%)	5 of 6 (83.3%)	0 of 6
Part B - 4.5mg Tirzepatide	0 of 6 (0%)	6 of 6 (100%)	0 of 6
Part B - 5, 5, 8,10mg Tirzepatide	0 of 7 (0%)	6 of 7 (85.7%)	0 of 7
Part C - Placebo	0 of 11 (0%)	3 of 11 (27.3%)	0 of 11
Part C - 0.5mg Tirzepatide	0 of 9 (0%)	5 of 9 (55.6%)	0 of 9
Part C - 5mg Tirzepatide	0 of 9 (0%)	7 of 9 (77.8%)	0 of 9
Part C - 5, 5, 10,10mg Tirzepatide	0 of 12 (0%)	10 of 12 (83.3%)	0 of 12
Part C - 5, 5, 10,15mg Tirzepatide	0 of 12 (0%)	11 of 12 (91.7%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30473097Coskun T, Sloop KW, Loghin C, Alsina-Fernandez J, Urva S, Bokvist KB, Cui X, Briere DA, Cabrera O, Roell WC, Kuchibhotla U, Moyers JS, Benson CT, Gimeno RE, D'Alessio DA, Haupt A. LY3298176, a novel dual GIP and GLP-1 receptor agonist for the treatment of type 2 diabetes mellitus: From discovery to clinical proof of concept. Mol Metab. 2018 Dec;18:3-14. doi: 10.1016/j.molmet.2018.09.009. Epub 2018 Oct 3.
Click here for more information about this study:A Study of tirzepatide in Participants With Type 2 Diabetes (T2DM)Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tirzepatide and Dulaglutide in people with Healthy and Type 2 Diabetes Mellitus (T2DM), run by Eli Lilly and Company at 2 sites in 2 countries.

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 3 inclusion and 7 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 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Singapore. 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 16 Jan 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 With One or More Serious Adverse Event(s) (SAEs) (time frame: Baseline through Day 43 (Part A) and Day 57 (Part B and C)). 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 NCT02759107, which also lists 1 linked publication.

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 16 Jan 2024.