Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PF-06882961 · 13 trials · 12 indications
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100 multiply by \[\*\](back-transformed LS Mean minus \[-\] 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
Percent change from baseline in body weight at end of treatment was reported in this outcome measure. Analysis was performed using MMRM with treatment, time, strata (females versus males) and treatment-by-time interaction as fixed effects, natural log-transformed baseline as a covariate and the (natural log-transformed baseline)-by-time interaction with time fitted as a repeated effect and participant as a random effect. Values were back-transformed from the log scale. Percent change = 100\*(back-transformed LS Mean - 1). Baseline was defined as the average of the duplicate measurements collected closest prior to dosing at Day 1.
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were events between first dose of study drug and up to follow-up visit that were absent before treatment or that worsened after treatment. AEs presented below were TEAEs. The investigator was required to use clinical judgment to assess the potential relationship between investigational product and each AE, to define an treatment-related AE. Assessments of AE intensity were defined as mild (easily tolerated, causing minimal discomfort and not interfering with daily activities), moderate (causing sufficient discomfort and interferes with normal daily activities) and severe (preventing normal daily activities).
HbA1c can be used as a diagnostic test for diabetes. The target HbA1c level for people with diabetes is usually less than 7%.
Atorvastatin was given on Day 1 in Periods 1, 4 and 7 of Part A and blood samples were collected for atorvastatin pharmacokinetic (PK) at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Midazolam was given on Day 1 in Periods 2, 5 and 8 of Part A and blood samples were collected for midazolam PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Levonorgestrel was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for levonorgestrel PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
Ethinyl estradiol (EE) was given on Day 1 in Periods 1, 3 and 5 of Part B and blood samples were collected for ethinyl estradiol PK at the preset time points described in the Time Frame. AUCinf calculated area under the plasma concentration-time profile from time 0 extrapolated to infinite time.
AUC24 is the area under the plasma concentration-time profile from time zero to the time 24 hours. The planned analysis was not considered reliable by the sponsor.
Cmax is the maximum observed plasma concentration over 24 hours. The planned analysis was not considered reliable by the sponsor.
AUC24 was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Cmax,ss was measured on Day 21, 35, and 56 for dose 40 mg BID, 80 mg BID, and 120 mg BID, respectively. The planned analysis was not considered reliable by the sponsor.
Cmax was the maximum observed plasma concentration and was directly observed from data.
AUCinf was defined as area under the plasma concentration-time curve from time zero to infinity.
AUClast was area under the plasma concentration time-curve from zero (pre-dose) to the last measured concentration.
Fu was defined as fraction of unbound drug in plasma.
Maximum observed plasma PF-06882961 concentration.
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to infinite time.
Area under the plasma PF-06882961 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.
fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).
AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.
AUClast is area under the plasma concentration-time profile from time 0 to last quantifiable concentration.
An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/ incapacity; congenital anomaly. Treatment emergent AEs were events between first dose of study drug and approximately 4 weeks after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and all non-serious AEs.
Leukocytes (10\^9/liter \[L\]) bilirubin (micromol/L), glucose (millimoles \[mmol\]/L), triacylglycerol lipase (microkatals \[microkat\]/L): greater than (\>) 1.5\*upper limit normal (ULN); activated partial thromboplastin time (s): 1.1\*ULN; HDL cholesterol (mmol/L), thyroid stimulating hormone (TSH) (milliunits \[mU\]/L): less than (\<) 0.8\*lower limit normal (LLN); LDL cholesterol (mmol/L), urate (mmol/L): \>1.2\*ULN; triglycerides: \>1.3\*ULN; aspartate aminotransferase (microkat/L), alanine aminotransferase (microkat/L), gamma glutamyl transferase (microkat/L): \>3.0\*ULN; cholesterol (mmol/L): \>1.3\*ULN; urine glucose, ketones urine protein, urine hemoglobin, urobilinogen, nitrite, leukocyte esterase: greater than or equal to (\>=) 1; granular casts, hyaline casts: \>1.
Supine systolic blood pressure (SBP) measured in millimeter of mercury (mmHg) had following categories: minimum of absolute SBP \<90 mmHg, maximum of SBP \>=30 mmHg decrease from baseline and maximum of SBP \>=30 mmHg increase from baseline. Supine diastolic blood pressure (DBP) measured in mmHg had following categories: minimum of absolute DBP \<50 mmHg, maximum of DBP \>20 mmHg decrease from baseline and maximum of DBP \>=20 mmHg increase from baseline. Supine pulse rate measured in beats per minute (BPM) had following categories: minimum of absolute supine pulse rate \<40 BPM and maximum of absolute supine pulse rate \>120 BPM. Baseline was defined as the time-matched value from the average of the triplicate recordings on Day -1.
PR interval had following categories: maximum absolute PR interval \>=300 milliseconds (msec); when baseline PR interval \>200 msec and maximum increase from baseline in PR interval \>=25 percent; when baseline PR interval less than or equal to (\<=) 200 msec and maximum increase from baseline in PR interval \>=50 percent. QRS interval had following categories: maximum absolute QRS interval \>=140 msec; maximum increase from baseline in QRS interval \>=50 percent. QTC interval with Frederica's correction (QTCF) had following categories: absolute QTCF interval \>450 msec to \<=480 msec; absolute QTCF interval \>480 msec to \<=500 msec; absolute QTCF interval \>500 msec; QTCF interval increase from baseline \>=30 msec to \<=60 msec; QTCF interval increase from baseline \>60 msec.
Total recovery of radioactivity in urine and feces, and both routes combined, expressed as a percent of total oral radioactive dose administered.
Treatment-related adverse event (AE) was any untoward medical occurrence attributed to study treatment in a participant who received study treatment. A serious AE (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening; initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect. Any such events with initial onset or increasing in severity after the first dose of study treatment were counted as treatment-emergent.
Following laboratory parameters were assessed against pre-defined abnormality criteria: hematology (hemoglobin, hematocrit, erythrocytes, reticulocytes, platelets, leukocytes, lymphocytes, neutrophils, basophils, eosinophils, monocytes, activated partial thromboplastin time, prothrombin time \[PT\], PT/international normalized ratio, reticulocytes); chemistry (indirect bilirubin, direct bilirubin, protein, albumin, blood urea nitrogen, creatinine, creatine kinase, urate, calcium, sodium, potassium, chloride, bicarbonate, urine urobilinogen); urinalysis (pH, urine glucose, urine ketones, urine protein, urine hemoglobin, nitrites, leukocyte esterase, urine erythrocytes, urine leukocytes, urine hyaline casts, urine bilirubin).
Vital signs categorical summarization criteria: 1) supine systolic blood pressure (SBP) \<90 millimeters of mercury (mmHg); 2) supine diastolic blood pressure (DBP) \<50 mmHg; 3) supine pulse rate \<40 or \>120 beats per minute (bpm); 4) change from baseline (increase or decrease) in supine SBP greater than or equal to (\>=) 30 mmHg; 5) change from baseline (increase or decrease) in supine DBP \>= 20 mmHg.
ECG categorical summarization criteria: 1. PR interval (the interval between the start of the P wave and the start of the QRS complex, corresponding to the time between the onset of the atrial depolarization and onset of ventricular depolarization): a) greater than or equal to (\>=) 300 millisecond (msec), b) \>=25% increase when baseline is \> 200 msec or \>=50% increase when baseline is less than or equal to (\<=) 200 msec. 2\. QRS duration (time from ECG Q wave to the end of the S wave corresponding to ventricle depolarization): a) \>=140 msec, b) \>=50% increase from baseline. 3\. QTcF interval (QT corrected using the Fridericia formula): a) \>450 msec and \<=480 msec, b) \>480 msec and \<=500 msec, c) \>500 msec, d) \>30 msec and \<=60 msec increase from baseline, e) \>60 msec increase from baseline
Assessment by adverse event monitoring, 12 lead ECGs, cardiac telemetry, vital signs and clinical safety laboratory measurements.
| Arm | Type | Description |
|---|---|---|
| Placebo (Cohorts 1 and 2) | PLACEBO_COMPARATOR | - |
| PF-06882961 40 milligrams (mg) twice daily (BID), 1-week titration (Cohort 1) | EXPERIMENTAL | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 40 mg BID. |
| PF-06882961 80 mg BID, 1-week titration (Cohort 1) | EXPERIMENTAL | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 80 mg BID. |
| PF-06882961 120 mg BID, 1-week titration (Cohort 1) | EXPERIMENTAL | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 120 mg BID. |
| PF-06882961 160 mg BID, 1-week titration (Cohort 1) | EXPERIMENTAL | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 160 mg BID. |
| PF-06882961 200 mg BID, 1-week titration (Cohort 1) | EXPERIMENTAL | The dose will be titrated with 1 week of dosing at each step to reach the target dose of 200 mg BID. |
| PF-06882961 120 mg BID, 2-week titration (Cohorts 1 and 2) | EXPERIMENTAL | The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 120 mg BID. |
| PF-06882961 160 mg BID, 2-week titration (Cohorts 1 and 2) | EXPERIMENTAL | The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 160 mg BID. |
| PF-06882961 200 mg BID, 2-week titration (Cohorts 1 and 2) | EXPERIMENTAL | The dose will be titrated with 2 weeks of dosing at each step to reach the target dose of 200 mg BID. |
| Placebo (Cohort 3) | PLACEBO_COMPARATOR | - |
| PF-06882961 80 mg BID, 4-week titration (Cohort 3) | EXPERIMENTAL | The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 80 mg BID. |
| PF-06882961 140 mg BID, 4-week titration (Cohort 3) | EXPERIMENTAL | The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 140 mg BID. |
| PF-06882961 200 mg BID, 4-week titration (Cohort 3) | EXPERIMENTAL | The dose will be titrated with 4 weeks of dosing at each step to reach the target dose of 200 mg BID. |
| Arm 1-PF-06882961 starting dose of 5 milligram (mg) BID titrated to 120 mg in participants with T2DM | EXPERIMENTAL | The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 120 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID |
| Arm 2-PF-06882961 starting dose of 10 mg BID titrated to 100 mg in participants with T2DM | EXPERIMENTAL | The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 120 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID |
| Arm 3-PF-06882961 starting dose of 5 mg BID titrated to 80 mg in participants with T2DM | EXPERIMENTAL | The dose will be titrated over 12 weeks, starting with a dose of 5 mg BID to reach the target dose of 80 mg BID. Titration steps include: 5 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID |
| Arm 4-PF-06882961 starting dose of 10 mg BID titrated to 80 mg in participants with T2DM | EXPERIMENTAL | The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 80 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID and 80 mg BID |
| Arm 5 - Placebo in subjects with T2DM and Obesity | PLACEBO_COMPARATOR | Matching Placebo tablets taken twice a day (BID) |
| Arm 6-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with T2DM | EXPERIMENTAL | The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID |
| Arm 7-PF-06882961 starting dose of 10 mg BID titrated to 200 mg in participants with Obesity | EXPERIMENTAL | The dose will be titrated over 12 weeks, starting with a dose of 10 mg BID to reach the target dose of 200 mg BID. Titration steps include: 10 mg BID, 20 mg BID, 40 mg BID, 60 mg BID, 80 mg BID, 100 mg BID and 120 mg BID,140 mg BID, 160 mg BID, 180 MG BID, 200 mg BID |
| Placebo | PLACEBO_COMPARATOR | - |
| PF-06882961 2.5 milligrams (mg) | EXPERIMENTAL | - |
| PF-06882961 10 mg | EXPERIMENTAL | - |
| PF-06882961 40 mg | EXPERIMENTAL | Participants will be titrated up to 2 weeks to reach desired dose level |
| PF-06882961 80 mg | EXPERIMENTAL | Participants will be titrated up to 4 weeks to reach desired dose level |
| PF-06882961 120 mg | EXPERIMENTAL | Participants will be titrated up to 6 weeks to reach desired dose level |
| Part A | EXPERIMENTAL | To evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of atorvastatin (20 mg tablet) and midazolam (5 mg syrup). |
| Part B | EXPERIMENTAL | To evaluate the effect of 2 steady-state dose levels of PF-06882961 on the Single Dose pharmacokinetics of an Oral Contraceptive (Levonorgestrel 0.15 mg and Ethinyl Estradiol 0.03 mg tablet). |
| PF-06882961 | EXPERIMENTAL | Participants will be titrated up to 6 weeks of the 8-week dosing duration to reach desired dose level 120 mg |
| Healthy participants with normal renal function | EXPERIMENTAL | This arm includes participants with normal renal function who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1 |
| Participants with T2DM with normal renal function | EXPERIMENTAL | This arm includes participants with Type 2 Diabetes Mellitus (T2DM) with normal renal function who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| Participants with T2DM with mild renal impairment | EXPERIMENTAL | This arm includes participants with Type 2 Diabetes Mellitus (T2DM) with mild renal impairment who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| Participants with T2DM with moderate renal impairment | EXPERIMENTAL | This arm includes participants with Type 2 Diabetes Mellitus (T2DM) with moderate renal impairment who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| Participants with T2DM with severe renal impairment | EXPERIMENTAL | This arm includes participants with Type 2 Diabetes Mellitus (T2DM) with severe renal impairment who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| PF-06882961 participants without Hepatic Impairment | EXPERIMENTAL | This arm includes participants who will receive an oral dose of PF-06882961 20 milligrams (mg) on Day 1 |
| PF-06882961 participants with mild Hepatic Impairment | EXPERIMENTAL | This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| PF-06882961 participants with moderate Hepatic Impairment | EXPERIMENTAL | This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| PF-06882961 participants with severe Hepatic Impairment | EXPERIMENTAL | This arm includes participants who will receive an oral dose of PF-06882961 20 mg on Day 1 |
| Period 1 | OTHER | Participants will receive the following treatments in this sequence : (i)Rosuvastatin alone (one dose of 10 mg), (ii) Midazolam alone (one dose of 2mg), (iii) PF 06882961 alone (120 mg twice daily), (iv) PF 06882961 (120 mg twice daily) + Rosuvastatin (one dose of 10mg), (v) PF 06882961 (120 mg) + Midazolam (one dose of 2 mg), (vi) PF 06882961 (200 mg) alone, (vii) PF 06882961 (200 mg) + Rosuvastatin (one dose of 10 mg), (viii) PF 06882961 (200 mg)+ Midazolam (one dose of 2 mg) in the study. |
| Formulation A (Cohort 1) | ACTIVE_COMPARATOR | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation A at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation B (Cohort 1) | EXPERIMENTAL | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation B at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation C (Cohort 1) | EXPERIMENTAL | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation C at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation D (Cohort 1) | EXPERIMENTAL | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation D at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation A (Cohort 2) | ACTIVE_COMPARATOR | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation A at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Formulation E (Cohort 2) | EXPERIMENTAL | Following an overnight fast of at least 10 hours, subjects received PF-06882961 (Danuglipron) 100 mg immediate release tablet as formulation E at approximately 0800 hours (±2 hours). A minimum of 72 hours between the single 100 mg doses administered in each period was employed |
| Oral [14C]PF-06882961, 50 mg | EXPERIMENTAL | In this arm, a single oral dose of \[14C\]PF-06882961, 50 mg will be administered as a liquid formulation. |
| Oral PF-06882961 50 mg and intravenous [14C]PF-06882961 100 ug | EXPERIMENTAL | In this arm, single oral dose of unlabeled PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of \[14C\]PF-06882961, 100 ug, will be administered via intravenous infusion. |
| PF-06882961 30 mg | EXPERIMENTAL | - |
| PF-06882961 100 mg | EXPERIMENTAL | - |
| PF-06882961 300 mg | EXPERIMENTAL | - |
| PF-06882961 600 mg | EXPERIMENTAL | - |
| PF-06882961 dose TBD Cohort 5 | EXPERIMENTAL | - |
| PF-06882961 dose TBD Cohort 6 | EXPERIMENTAL | - |
| PF-06882961 dose TBD Cohort 7 | EXPERIMENTAL | - |
| PF-06882961 dose TBD Cohort 8 | EXPERIMENTAL | - |
| Cohort 1 | EXPERIMENTAL | Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject. |
| Cohort 2 | EXPERIMENTAL | Single Ascending Dose in crossover design with placebo substitution. Administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject. |
| Cohort 3 (optional) | EXPERIMENTAL | Single Ascending Dose administration under fed or fasted conditions as tablet or solution formulation. At least 7 days washout between doses in an individual subject. |
| Name | Type | Description |
|---|---|---|
| Placebo (Cohorts 1 and 2) | DRUG | 4 matching placebo tablets taken twice daily |
| PF-06882961 (Cohorts 1 and 2) | DRUG | Participants will be randomized to one of 5 active target dose levels (40, 80, 120, 160 or 200 mg BID) achieved through 1-week titration steps, or 3 active target dose levels (120, 160 or 200 mg BID) achieved through 2-week titration steps, taking 4 tablets twice daily |
| Placebo (Cohort 3) | DRUG | 2 matching placebo tablets taken twice daily |
| PF-06882961 (Cohort 3) | DRUG | Participants will be randomized to one of 3 active target dose levels (80, 140 or 200 mg BID) achieved through 4-week titration steps, taking 2 tablets twice daily. |
| PF-06882961 | DRUG | PF-68882961 will be provided as tablets twice a day (BID) |
| Placebo | OTHER | Placebo comparator will be provided as tablets twice daily for 12 weeks |
| Atorvastatin | DRUG | Tablets |
| Midazolam | DRUG | Syrup |
| Levonorgestrel & Ethinyl Estradiol | DRUG | Tablet |
| PF-06882961 20 mg | DRUG | PF-06882961 20 mg single oral dose provided in tablet form administered in a fed state on Day 1 |
| PF-06882961 20MG | DRUG | PF-06882961 in 20 mg oral tablet will be administered on Day 1 |
| Rosuvastatin | DRUG | 10 mg single dose |
| PF-06882961 100 mg | DRUG | PF-06882961 100 mg will be provided in 5 different oral formulations A, B, C, D, and E. Cohort 1 is a randomized, open-label, single dose, 4-period, 4-sequence, crossover design where the first 2 periods are cross-over (Formulations A and B) and the second 2 periods are crossover (Formulations C and D). Cohort 2 is a randomized, open-label, single dose, 2-period, 2 sequence, crossover design (Formulations A and E) |
| [14C]PF-06882961, 50 mg | DRUG | A single oral dose of \[14C\]PF-06882961, will be administered as a liquid formulation. |
| PF-06882961, 50 mg and [14C]PF-06882961, 100 ug | DRUG | A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of \[14C\]PF-06882961 will be administered via intravenous infusion. |
Inclusion Criteria: * Participants with obesity, defined as a Body Mass Index greater than or equal to 30.0 kg/m2 * Stable body weight, defined as \<5 kg change (per participant report) for 90 days before visit 1 Exclusion Criteria: * Any condition possibly affecting drug absorption * Current or ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| FibroBiologics, Inc. | FBLG | 1 | PHASE1 | Undisclosed |
| MiMedx Group, Inc. | MDXG | 2 | N/A | Undisclosed |
| Integra LifeSciences Holdings Corporation | IART | 1 | N/A | Undisclosed |
| Organogenesis Holdings, Inc. Class A | ORGO | 1 | N/A | Undisclosed |
| Healthcare Services Group, Inc. | HCSG | 1 | N/A | Undisclosed |
PF-06882961 is an investigational small molecule being studied for metabolic conditions including type 2 diabetes mellitus, overweight, and obesity. It has been evaluated in clinical trials enrolling healthy subjects, healthy adults, and patients with type 2 diabetes. The drug is in Phase 2 development.
PF-06882961 is being developed by Pfizer, Inc., a biopharmaceutical company listed on the New York Stock Exchange under the ticker symbol PFE. The drug is an investigational small molecule in Phase 2 clinical development for metabolic indications.
PF-06882961 is in Phase 2 clinical development. It is an investigational drug, not yet approved by regulatory authorities. Completed Phase 1 trials have assessed the drug in patients with type 2 diabetes and in participants who are overweight or have obesity.
PF-06882961 has been studied in several completed Phase 1 trials. NCT03538743 evaluated multiple doses in patients with type 2 diabetes. NCT04552470 studied the drug in Japanese adults with type 2 diabetes. NCT04616339 compared different oral formulations in participants who are overweight or have obesity. NCT05093205 assessed effects on other medications in healthy adults.
PF-06882961 is also known by the name danuglipron. It is an investigational small molecule being developed by Pfizer for metabolic conditions such as type 2 diabetes and obesity. The drug is currently in Phase 2 clinical development.
PF-06882961 is a small molecule that acts as an agonist of the glucagon-like peptide-1 receptor. By targeting this receptor, the drug is designed to influence metabolic pathways relevant to conditions like type 2 diabetes and obesity. It is being developed by Pfizer.