Approval Probability
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Also known as Oxyntomodulin (OXM)
Oxyntomodulin · 2 trials · 2 indications
Participants received on Day (-1) an overnight intravenous (IV) infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of liraglutide (Lg) or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of graded glucose infusion (GGI). During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI at the following minutes: 0, 20, 40, 60, 80, 100, 120, 140, 160 and 165 in order to calculate the time-weighted average change from baseline in glucose AUC from 0-160 minutes.
Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting approximately 40 minutes. Glucose levels were measured from blood collected at baseline and during GGI to determine the maximum ambient glucose concentration above baseline.
Beta cell sensitivity measures the ability to mount an insulin secretory response relative to the level of ambient plasma glucose. Participants received on Day (-1) an overnight IV infusion of insulin titrated to achieve baseline fasting plasma glucose on Day 1 of between 90 and 130 mg/dL. Participants also received on Day (-1) a single dose of Lg or placebo for Lg, after which insulin infusion was discontinued. Following overnight fast, participants received on Day 1 a single dose of OXM or placebo for OXM, accompanied by up to 160 minutes of GGI. During GGI glucose (20% D/W) was gradually infused at rates of 2,4,6 and 10 mg/kg/min, with each rate lasting 40 minutes. Glucose (G), insulin and C-peptide levels were measured from blood collected at baseline and during GGI, with the decay in C-peptide concentration used to indirectly estimate the Insulin Secretion Rate (ISR). Beta Cell Sensitivity (Φ) was determined from the regression of the ISR on ambient plasma glucose (G).
| Arm | Type | Description |
|---|---|---|
| OXM → Lg-0.6 → Pbo → Lg-1.2 | EXPERIMENTAL | Participants received Oxyntomodulin 3.0 pmol/kg/min in the first, Liraglutide 0.6 mg in the second, Placebo in the third, and Liraglutide 1.2 mg in the fourth period |
| Lg-0.6 → Pbo → OXM → Pbo | EXPERIMENTAL | Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period |
| Pbo → OXM → Lg-0.6 → Pbo | EXPERIMENTAL | Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period |
| Lg-0.6 → OXM → Pbo → Lg-1.2 | EXPERIMENTAL | Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period |
| OXM → Pbo → Lg-0.6 → Pbo | EXPERIMENTAL | Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period |
| Pbo → Lg-0.6 → OXM → Lg-1.2 | EXPERIMENTAL | Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period |
| Treatment sequence 1 | EXPERIMENTAL | OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min - Placebo |
| Treatment sequence 2 | EXPERIMENTAL | OXM 0.6 pmol/kg/min - Placebo - OXM 3.0 pmol/kg/min |
| Treatment sequence 3 | EXPERIMENTAL | Placebo - OXM 3.0 pmol/kg/min - OXM 0.6 pmol/kg/min |
| Treatment sequence 4 | EXPERIMENTAL | OXM 3.0 pmol/kg/min - Placebo - OXM 0.6 pmol/kg/min |
| Treatment sequence 5 | EXPERIMENTAL | Placebo - OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min |
| Treatment sequence 6 | EXPERIMENTAL | OXM 0.6 pmol/kg/min - OXM 3.0 pmol/kg/min - Placebo |
| Name | Type | Description |
|---|---|---|
| Oxyntomodulin | DRUG | 3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1) |
| Liraglutide 0.6 mg | DRUG | Single subcutaneous dose in the evening of the day before the GGI (Day-1) |
| Liraglutide 1.2 mg | DRUG | Single subcutaneous dose in the evening of the day before the GGI (Day-1) |
| Placebo for Oxyntomodulin | DRUG | IV infusion in the morning of the day of GGI (Day 1) |
| Placebo for Liraglutide | DRUG | Single subcutaneous dose in the evening of the day before the GGI (Day-1) |
| Oxyntomodulin (OXM) | DRUG | Single infusion of OXM 3.0 pmol/kg/min by IV |
| Comparator: Oxyntomodulin (OXM) | DRUG | Single infusion of OXM 0.6 pmol/kg/min by IV |
| Comparator: Placebo [ hemaccel-containing saline] | DRUG | Single Placebo infusion of hemaccel-containing saline by IV |
Inclusion Criteria: * Have a body mass index (BMI) of ≤38.0 kg/m\^2 * Have a clinical diagnosis of Type 2 diabetes mellitus * Have a glycated hemoglobin (HbA1C) at screening ≤9.0%; fasting plasma glucose should not exceed 300 mg/dL (16.8 mmol/L) * Judged to be in good health Exclusion Criteria: *...
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Oxyntomodulin is an investigational peptide therapeutic being developed by Merck & Company, Inc. (MRK) for the treatment of obesity and Type 2 Diabetes Mellitus. It is in Phase 1 clinical development and has been studied in early-stage trials evaluating metabolic and glucoregulatory effects in male participants.
Oxyntomodulin is being developed for obesity and Type 2 Diabetes Mellitus. Its clinical program has focused on evaluating glucoregulatory effects and metabolic methodologies in these conditions. It remains investigational and is not approved for any indication.
Oxyntomodulin is being developed by Merck & Company, Inc., which trades under the ticker MRK. The company has sponsored the Phase 1 clinical trials evaluating the drug in obesity and Type 2 Diabetes Mellitus.
Oxyntomodulin is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA for any indication. Its trials to date have been early-stage studies in male participants with Type 2 Diabetes Mellitus or in healthy male volunteers.
Oxyntomodulin has been evaluated in Phase 1 trials including NCT01373450, which studied glucoregulatory effects of GLP-1 receptor activation in participants with Type 2 Diabetes Mellitus, and NCT01055340, which evaluated ketogenesis and glucose-dependent insulin secretion methodologies in healthy male subjects. Both trials are completed.
Yes, Oxyntomodulin is also known as Oxyntomodulin (OXM). OXM is simply the abbreviated form of the same investigational peptide being developed by Merck & Company, Inc. for obesity and Type 2 Diabetes Mellitus.