A study to compare a new drug for Type 2 Diabetes to placebo (a placebo looks like the study drug but has no medicine) and to a treatment already available for Type 2 Diabetes.

Comparison of the Oxyntomodulin Analog, LY2944876, to Once-Weekly Exenatide and to Placebo in Patients with Type 2 Diabetes.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003552-21-GR

Enrollment

375

Registered

2014-03-28

Start date

2014-05-27

Completion date

Unknown

Last updated

2016-06-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2 MedDRA version: 16.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861

Interventions

Product Name: Oxyntomodulin analogue Product Code: LY2944876 Pharmaceutical Form: Powder for solution for injection Other descriptive name: LY2944876 Concentration unit: mg/ml milligram(s)/millilitre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men or women aged 18 to 80 years with T2DM. Eligibility criteria include: HbA1c =7.0% and =10.5% at screening and treated with diet and exercise alone or on a stable dose of metformin (=1000 mg/day) for 3 months prior to screening. BMI =23 and =45 kg/m2 at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 337 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38

Exclusion criteria

Exclusion criteria: Patients are excluded from participation if they; are women of child bearing potential; used thiazolidinediones within 3 months prior to screening, or any other drugs for treatment of hyperglycemia (except metformin) within the prior 2 months; have used insulin for diabetic control for more than 6 consecutive days within the prior year; and if they have impaired renal function (serum creatinine >124 µmol/L [1.4 mg/dL] in women, >133 µmol/L [1.5 mg/dL] in men).

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate a dose-response relationship of once-weekly subcutaneous injections of LY2944876 on hemoglobin A1c (HbA1c) change from baseline, and from this dose-response relationship at 12 weeks determine which LY2944876 doses are superior to placebo in patients with T2DM inadequately controlled with diet and exercise alone or treated with a stable dose of metformin.;Secondary Objective: To determine the effect of LY2944876 versus exenatide ER (and to compare the effect of both vs. placebo) on: • Mean % body weight change from baseline to 12 and 24 weeks • Safety and tolerability, including gastrointestinal tolerability, incidence and rate of hypoglycemia, hypersensitivity reactions, and pancreatic safety • Change from baseline of HbA1c at 24 weeks • Percentage of patients with 5% or greater body weight loss at 24 weeks • Change from baseline of fasting blood glucose at 12 and 24 weeks To evaluate the development of treatment-emergent anti-drug antibodies to LY2944876 or polyethylene glycol. To assess pharmacokinetics (PK) of LY2944876, its variability and potential patient factors that may influence its PK. To assess the relationship between LY2944876 dose and/or exposure and efficacy, and safety measures, where applicable. ;Primary end point(s): The primary efficacy endpoint is HbA1c change from baseline to 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks	—

Measure

Time frame

Main Objective: To demonstrate a dose-response relationship of once-weekly subcutaneous injections of LY2944876 on hemoglobin A1c (HbA1c) change from baseline, and from this dose-response relationship at 12 weeks determine which LY2944876 doses are superior to placebo in patients with T2DM inadequately controlled with diet and exercise alone or treated with a stable dose of metformin.;Secondary Objective: To determine the effect of LY2944876 versus exenatide ER (and to compare the effect of both vs. placebo) on: • Mean % body weight change from baseline to 12 and 24 weeks • Safety and tolerability, including gastrointestinal tolerability, incidence and rate of hypoglycemia, hypersensitivity reactions, and pancreatic safety • Change from baseline of HbA1c at 24 weeks • Percentage of patients with 5% or greater body weight loss at 24 weeks • Change from baseline of fasting blood glucose at 12 and 24 weeks To evaluate the development of treatment-emergent anti-drug antibodies to LY2944876 or polyethylene glycol. To assess pharmacokinetics (PK) of LY2944876, its variability and potential patient factors that may influence its PK. To assess the relationship between LY2944876 dose and/or exposure and efficacy, and safety measures, where applicable. ;Primary end point(s): The primary efficacy endpoint is HbA1c change from baseline to 12 weeks;Timepoint(s) of evaluation of this end point: 12 weeks

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Secondary

Measure	Time frame
Secondary end point(s): Secondary efficacy measures include: HbA1c, body weight (mean change from baseline and % of patients with > 5% loss from baseline to endpoint), fasting blood glucose; 7 point SMBG profiles; % of patients requiring rescue therapy, lipids, and other circulating biomarkers. Safety: Vital signs, labs, ECG monitoring, incidence and duration of nausea, vomiting, and diarrhea, assessment of injection site reactions, hypersensitivity reactions, episodes of hypoglycemia, acute pancreatitis , major adverse cardiovascular events, development of anti-drug antibodies, and TEAEs including SAEs and AEs leading to discontinuation. Health Outcomes: APPADL and IW-SP questionnaires, which are self-rated questionnaires that provide standardized measures of patients’ perceived current health status. Pharmacokinetic: Venous blood samples to measure the plasma concentrations of LY2944876 using validated bioanalytical assays. Pharmacodynamic: Endpoints may include, but are not necessarily limited to, endpoints for efficacy (glucose, HbA1c, weight), tolerability (e.g., nausea and vomiting), safety (e.g., corrected QT (QTc) interval, heart rate), and biomarkers (e.g., insulin, glucagon). ;Timepoint(s) of evaluation of this end point: 12 and 24 weeks	—

Measure

Time frame

Secondary end point(s): Secondary efficacy measures include: HbA1c, body weight (mean change from baseline and % of patients with > 5% loss from baseline to endpoint), fasting blood glucose; 7 point SMBG profiles; % of patients requiring rescue therapy, lipids, and other circulating biomarkers. Safety: Vital signs, labs, ECG monitoring, incidence and duration of nausea, vomiting, and diarrhea, assessment of injection site reactions, hypersensitivity reactions, episodes of hypoglycemia, acute pancreatitis , major adverse cardiovascular events, development of anti-drug antibodies, and TEAEs including SAEs and AEs leading to discontinuation. Health Outcomes: APPADL and IW-SP questionnaires, which are self-rated questionnaires that provide standardized measures of patients’ perceived current health status. Pharmacokinetic: Venous blood samples to measure the plasma concentrations of LY2944876 using validated bioanalytical assays. Pharmacodynamic: Endpoints may include, but are not necessarily limited to, endpoints for efficacy (glucose, HbA1c, weight), tolerability (e.g., nausea and vomiting), safety (e.g., corrected QT (QTc) interval, heart rate), and biomarkers (e.g., insulin, glucagon). ;Timepoint(s) of evaluation of this end point: 12 and 24 weeks

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Countries

Greece, Mexico, Poland, Romania, Spain, United States

Contacts

Public ContactClinical Trial Registry Office

Eli Lilly and Company

EU_Lilly_Clinical_Trials@lilly.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026