Type 2 Diabetes MellitusPhase 2NCT03254368
Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes
A Phase 2 study testing ZGN-1061 in people with Type 2 Diabetes Mellitus and Overweight and Obesity, run by Zafgen, Inc. at 23 sites in 2 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus, Overweight and Obesity
- What is being tested?
- ZGN-1061
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 188 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 12 Sep 2017to 22 Feb 2019
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet the following criteria to participate in this study:
- Be between the ages of 18 and 70 years, inclusive.
- Overweight or obese with a body mass index of at least 27 kg/m².
- Have type 2 diabetes with HbA1c between 7% and 11%.
- For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor.
- For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery.
Who cannot join
- Subjects cannot participate in this research study if they meet any of the following:
- Have taken another study drug or study device within the past 6 months.
- Are taking certain prescribed medications including narcotics or opiates.
- Consistent recent use of insulin.
- Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study.
- Have a history of bleeding disorders or risk factors for excessive blood clotting.
- Have difficulty giving blood.
- Have a history of drug and/or alcohol abuse.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
Australia12 sites
Eastern Clinical Research Unit (ECRU)
Box Hill, Victoria, 3128
Coffs Harbour GP SuperClinic
Coffs Harbour, New South Wales, 2450
Northside Health
Coffs Harbour, New South Wales, 2450
Southern Adelaide Diabetes & Endocrine Services
Daw Park, South Australia, 5041
Barwon Health
Geelong, Victoria, 3218
Q-Pharm
Herston, Queensland, 4006
The Aim Centre
Merewether, New South Wales, 2291
Royal Melbourne Hospital
Parkville, Victoria, 3050
Griffith University, Gold Coast Campus
Southport, Queensland, 4222
The Boden Institute
Sydney, New South Wales, 2006
Holdsworth House Medical Practice
Sydney, New South Wales, 2010
Pendlebury Research
Sydney, New South Wales, 2289
New Zealand11 sites
Optimal Clinical Trials
Auckland, 1021
Middlemore Hospital
Auckland, 2025
Christchurch Diabetes Centre
Christchurch, 8011
Southern Clinical Trials
Christchurch, 8024
Lipid and Diabetes Research Group
Christchurch, 8140
Clinical Trials New Zealand Ltd
Hamilton, 3206
P3 Research Hawkes Bay
Hastings, 4130
P3 Research Wellington
Newtown, 6021
Lakeland Clinical Trials
Rotorua, 3010
P3 Research Tauranga
Tauranga, 3110
Wellington Hospital
Wellington, 6021
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of ZGN-1061 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Glycemic Control, Safety, and Tolerability Over 12 Weeks
The purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.
Read the detailed description
Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).
- Conditions
- Type 2 Diabetes Mellitus, Overweight and Obesity
- Being tested
- ZGN-1061, Placebo
- Keywords
- Methionine Aminopeptidase 2 Inhibitor, Diabetes Mellitus, Type 2, Blood Glucose, Overweight, Obesity
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ZGN-1061Drug
ZGN-1061 is a methionine aminopeptidase 2 inhibitor
PlaceboDrug
Placebo has the same excipients and appearance as ZGN-1061
| Study group | Role | What they receive |
|---|---|---|
| 0.05 mg ZGN-1061 (A) | Experimental | 0.05 mg ZGN-1061 subcutaneous injection once every 3 days Receives: Drug: ZGN-1061 |
| 0.3 mg ZGN-1061 (B) | Experimental | 0.3 mg ZGN-1061 subcutaneous injection once every 3 days Receives: Drug: ZGN-1061 |
| 0.9 mg ZGN-1061 (C) | Experimental | 0.9 mg ZGN-1061 subcutaneous injection once every 3 days Receives: Drug: ZGN-1061 |
| 1.8 mg ZGN-1061 (CC) | Experimental | 1.8 mg ZGN-1061 subcutaneous injection once every 3 days Receives: Drug: ZGN-1061 |
| Placebo (D) | Placebo comparator | Placebo subcutaneous injection once every 3 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: 12 weeks
Safety and tolerability as assessed by incidence of adverse events
Measured: 12 weeks
Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
Measured: 12 weeks
Secondary outcomes (13)
Change in body weight
Measured: 12 weeks
Change in fasting plasma glucose
Measured: 12 weeks
Change in insulin
Measured: 12 weeks
Change in C-peptide
Measured: 12 weeks
Change in proinsulin
Measured: 12 weeks
Change in glucagon
Measured: 12 weeks
Proportion of subjects achieving HbA1c <7% and ≤6.5%
Measured: 12 weeks
Change in beta-cell function
Measured: 12 weeks
Change in insulin sensitivity
Measured: 12 weeks
Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects
Measured: 12 weeks
Change in waist and hip circumference
Measured: 12 weeks
Change in biomarkers relevant to obesity and/or type 2 diabetes
Measured: 12 weeks
Change in patient reported outcomes measures
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2017
- Study start12 Sep 2017
- Primary completion12 Nov 2018
- Study completion22 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zafgen, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Kim, MD, Study chair, Zafgen, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03254368
- Sponsor's protocol ID
- ZAF-1061-201
- Other IDs
- U1111-1196-7527
- Status last verified
- May 2019
- First submitted
- 7 Aug 2017
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of ZGN-1061 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus to Evaluate Glycemic Control, Safety, and Tolerability Over 12 Weeks
- ClinicalTrials.gov ID
- NCT03254368
- Acronym / sponsor ID
- ZAF-1061-201
- Conditions
- Type 2 Diabetes Mellitus, Overweight and Obesity
- Keywords
- Methionine Aminopeptidase 2 Inhibitor, Diabetes Mellitus, Type 2, Blood Glucose, Overweight, Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Zafgen, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Sep 2017 (actual)
- Primary completion
- 12 Nov 2018 (actual)
- Study completion
- 22 Feb 2019 (actual)
- First posted
- 18 Aug 2017 (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 purpose of this study is to evaluate the efficacy and safety of the study drug ZGN-1061 in participants with type 2 diabetes.
Detailed description
Participants will be enrolled in 1 of 2 groups. Approximately 120 participants will receive 0.05, 0.3, or 0.9 mg of ZGN-1061 or placebo (Group 1). An additional 40 participants will receive 0.9 or 1.8 mg of ZGN-1061 or placebo (Group 2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 0.05 mg ZGN-1061 (A) | Experimental | Drug: ZGN-10610.05 mg ZGN-1061 subcutaneous injection once every 3 days |
| 0.3 mg ZGN-1061 (B) | Experimental | Drug: ZGN-10610.3 mg ZGN-1061 subcutaneous injection once every 3 days |
| 0.9 mg ZGN-1061 (C) | Experimental | Drug: ZGN-10610.9 mg ZGN-1061 subcutaneous injection once every 3 days |
| 1.8 mg ZGN-1061 (CC) | Experimental | Drug: ZGN-10611.8 mg ZGN-1061 subcutaneous injection once every 3 days |
| Placebo (D) | Placebo comparator | Drug: PlaceboPlacebo subcutaneous injection once every 3 days |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Be between the ages of 18 and 70 years, inclusive.
- Overweight or obese with a body mass index of at least 27 kg/m².
- Have type 2 diabetes with HbA1c between 7% and 11%.
- For subjects taking approved antidiabetes medications, the doses must be stable as determined by the study doctor.
- For subjects who have had weight-loss surgery (example: gastric banding), the procedure must have occurred at least 1 year ago, and be verified with documentation or by a health professional associated with the surgery.
Key exclusion criteria (8 listed)
- Have taken another study drug or study device within the past 6 months.
- Are taking certain prescribed medications including narcotics or opiates.
- Consistent recent use of insulin.
- Have had recent major surgery or prolonged bed rest, or planning or likely to undergo any surgery during the research study.
- Have a history of bleeding disorders or risk factors for excessive blood clotting.
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 |
|---|---|---|
| ZGN-1061ZGN-1061 is a methionine aminopeptidase 2 inhibitor | Drug | 0.05 mg ZGN-1061 (A), 0.3 mg ZGN-1061 (B), 0.9 mg ZGN-1061 (C), 1.8 mg ZGN-1061 (CC) |
| PlaceboPlacebo has the same excipients and appearance as ZGN-1061 | Drug | Placebo (D) |
Primary outcome
Change in HbA1c
Time frame: 12 weeks
Safety and tolerability as assessed by incidence of adverse events
Time frame: 12 weeks
Safety and tolerability as assessed by change in medication use, vital signs, physical examination findings, mental well-being questionnaires, laboratory evaluations, and electrocardiogram results
Time frame: 12 weeks
13 secondary outcomes
Change in body weight
Time frame: 12 weeks
Change in fasting plasma glucose
Time frame: 12 weeks
Change in insulin
Time frame: 12 weeks
Change in C-peptide
Time frame: 12 weeks
Change in proinsulin
Time frame: 12 weeks
Change in glucagon
Time frame: 12 weeks
Proportion of subjects achieving HbA1c <7% and ≤6.5%
Time frame: 12 weeks
Change in beta-cell function
Time frame: 12 weeks
Change in insulin sensitivity
Time frame: 12 weeks
Change in preprandial and postprandial glycemic parameters as assessed by a mixed meal tolerance test in a subset of subjects
Time frame: 12 weeks
Change in waist and hip circumference
Time frame: 12 weeks
Change in biomarkers relevant to obesity and/or type 2 diabetes
Time frame: 12 weeks
Change in patient reported outcomes measures
Time frame: 12 weeks
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 24 May 2019.
- Individual participant dataSharing planned: No
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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.
Dennis Kim, MD study chair
Zafgen, Inc.
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ZGN-1061 in people with Type 2 Diabetes Mellitus and Overweight and Obesity, run by Zafgen, Inc. at 23 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 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 24 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Australia, New Zealand. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in HbA1c (time frame: 12 weeks). The study lists 3 primary outcomes in all. 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 24 May 2019.