Trials Sponsors Conditions Drugs Pricing

Conditions

Overweight and Obesity Type 2 Diabetes Mellitus

Keywords

Methionine Aminopeptidase 2 InhibitorDiabetes Mellitus, Type 2Blood GlucoseOverweightObesity

Outcome Measures

Primary Outcomes (3)

Change in HbA1c
12 weeks
Safety and tolerability as assessed by incidence of adverse events
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
12 weeks

Secondary Outcomes (13)

Change in body weight
12 weeks
Change in fasting plasma glucose
12 weeks
Change in insulin
12 weeks
Change in C-peptide
12 weeks
Change in proinsulin
12 weeks
+8 more secondary outcomes

Study Arms (5)

0.05 mg ZGN-1061 (A)

EXPERIMENTAL

0.05 mg ZGN-1061 subcutaneous injection once every 3 days

Drug: ZGN-1061

0.3 mg ZGN-1061 (B)

EXPERIMENTAL

0.3 mg ZGN-1061 subcutaneous injection once every 3 days

Drug: ZGN-1061

0.9 mg ZGN-1061 (C)

EXPERIMENTAL

0.9 mg ZGN-1061 subcutaneous injection once every 3 days

Drug: ZGN-1061

Interventions

ZGN-1061Drug

ZGN-1061 is a methionine aminopeptidase 2 inhibitor

0.05 mg ZGN-1061 (A)0.3 mg ZGN-1061 (B)0.9 mg ZGN-1061 (C)1.8 mg ZGN-1061 (CC)

PlaceboDrug

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects must meet the following criteria to participate in this study:
Be between the ages of 18 and 70 years, inclusive.

Sponsors & Collaborators

Zafgen, Inc.
Industrylead

Study Sites (23)

Coffs Harbour GP SuperClinic

Coffs Harbour, New South Wales, 2450, Australia

Northside Health

Coffs Harbour, New South Wales, 2450, Australia

The Aim Centre

Merewether, New South Wales, 2291, Australia

The Boden Institute

Sydney, New South Wales, 2006, Australia

Holdsworth House Medical Practice

Sydney, New South Wales, 2010, Australia

Pendlebury Research

Sydney, New South Wales, 2289, Australia

Q-Pharm

Herston, Queensland, 4006, Australia

MeSH Terms

Conditions

Diabetes Mellitus, Type 2OverweightObesity

Interventions

ZGN-1061

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

Dennis Kim, MD
Zafgen, Inc.
STUDY CHAIR

Enrollment

188 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 7, 2017

First Posted

August 18, 2017

Study Start

September 12, 2017

Actual (reported)

Study to Assess the Effects and Safety of ZGN-1061 in Overweight and Obese Participants With Type 2 Diabetes

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (13)

Study Arms (5)

0.05 mg ZGN-1061 (A)

0.3 mg ZGN-1061 (B)

0.9 mg ZGN-1061 (C)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

1.8 mg ZGN-1061 (CC)

Placebo (D)

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (3)

Secondary Outcomes (13)

Study Arms (5)

0.05 mg ZGN-1061 (A)

0.3 mg ZGN-1061 (B)

0.9 mg ZGN-1061 (C)

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (23)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

1.8 mg ZGN-1061 (CC)

Placebo (D)

You may not qualify if:

Data Sharing

Source record

Locations