Weight Loss – MALES ONLY - Pfizer C3991004 - A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE RANGING, DOSE FINDING, PARALLEL GROUP STUDY TO ASSESS EFFICACY AND SAFETY OF PF-07081532, AND OPEN LABEL ORAL SEMAGLUTIDE (RYBELSUS).
1. MALES ONLY 18 years or older (or the minimum age of consent in accordance with local regulations) and up to 75 years, inclusively, at the Screening Visit.
2. TYPE 2 DIABETICS
a. Participants diagnosed with TYPE 2 DIABETES inadequately controlled with metformin at doses ≥500 mg/day (and up to the highest approved,
in country dose) with metformin dose stable for ≥8 weeks prior to Screening Visit;
b. BMI ≥23.0 kg/m2
c. HbA1C of 7% to 10%
d. FPG ≤270 mg/dL
3. NON-DIABETICS
e. Participants with obesity, defined by BMI ≥30.0 kg/m2
f. HbA1C ≤6.4% (47 mmol/mol), at Screening Visit
g. FPG ≤126 mg/dL (7 mmol/L) at Screening Visit
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Novo Nordisk (NN4662) - (Kidney preservation with Semaglutide)
- Male or Female ≥ 18 years of age
- Diagnosed with Type 2 Diabetes ≥ 180 days prior to screening
- eGFR ≥ 40 and ≤ 75
- UACR ≥ 30 and ≤ 5000
- Treated with maximum labeled or tolerated dose of Blood Pressure Medications (stable for 28 days prior to screening)
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Novo Nordisk (NN4758 ZEUS) - (Effects of Ziltivekimab vs. Placebo on Cardio Vascular outcomes in participants with established atherosclerotic Cardio Vascular Disease, Chronic Kidney Disease and systemic inflammation)
- eGFR ≥15 and ≤ 59
- serum hs-CRP ≥ 2
- evidence of Atherosclerotic Cardio Vascular Disease by one or more of the following within the last 5 years from screening:
a) CHD defined as at least one of the following:
- documented history of Heart Attack
- prior coronary revascularisation procedure
- ≥ 50% stenosis in major epicardial coronary artery documented by cardiac catheterization or CT coronary angiography
b) Cerebrovascular disease defined as at least one to the following:
- prior stroke of atherosclerotic origin
- prior carotid artery revascularisation procedure
- ≥ 50% stenosis in carotid artery documented by X-Ray angiography, MR angiography, CT angiography or Doppler ultrasound.
c) Symptomatic Peripheral Artery Disease (PAD) defined as at least one of the following:
- intermittent claudication with ABI ≤ 0.90 at rest
- intermittent claudication with a ≥ 50% stenosis in peripheral artery (excluding carotid) documented by X-Ray angiography, MR
angiography, CT angiography or Doppler ultrasound
- prior peripheral artery (excluding Carotid) revascularisation procedure
- lower extremity amputation at or above the ankle due to atherosclerotic disease (excluding e.g. trauma or osteomyelitis)
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Novo Nordisk (NN4942 REDEFINE-3) The cardiovascular safety of cagrilintide 2.4 mg s.c. in combination with semaglutide 2.4 mg s.c. (CagriSema 2.4 mg/2.4 mg s.c.) once-weekly in participants with obesity and established cardiovascular disease
1. Male or female.
2. Age above or equal to 55 years at the time of signing informed consent.
3. Body mass index (BMI) ≥ 30.0 kg/m2
4. Have established CVD as evidenced by at least one of the following:
• _Prior myocardial infarction
• _Prior stroke (ischemic or haemorrhagic stroke)
• _Symptomatic peripheral arterial disease (PAD) defined as at least one of the following:
a. Intermittent claudication with an Ankle-brachial index (ABI) < 0.85 at rest
b. Intermittent claudication with a ≥ 50% stenosis in a lower extremity peripheral artery documented by X-ray angiography, MR angiography, CT
angiography or Doppler ultrasound
c. Prior revascularization procedure of a lower extremity peripheral artery
d. Lower extremity amputation at or above ankle due to atherosclerotic disease (excluding e.g., trauma or osteomyelitis)
For participants with T2D at screening:
5. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening
6. HbA1c 7%-10% (both inclusive).
7. Treatment with either:
a. Lifestyle intervention alone
b. 1-3 marketed oral antidiabetic drugs (OAD)s (_metformin, Treatment with oral antidiabetic drugs should be stable (same drug(s), dose and
dosing frequency) for at least 90 days before screening
c. Basal insulin alone or in combination with up to two marketed OADs (refer to b. above), all according to local label
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Sanofi - LPS17007: A Phase IV, 24-Week, Multicenter, Randomized, Open Label, Parallel-Group Trial Comparing the Efficacy and Safety of Insulin Glargine 300 U/mL (Gla 300) and Insulin Degludec 100 U/mL (IDeg 100) in Insulin Naïve People with Type 2 Diabetes Mellitus and Renal Impairment: TRENT Trial
1. Is an adult aged ≥18 years at screening.
2. Was diagnosed with T2DM of >1-year duration and had glycemic levels above target with OADs with or without GLP-1 RA (oral or injectable) at stable doses for ≥3 months before the screening period.
3. Has an HbA1c ≥7.5% and ≤10.5% at screening.
4. Has renal impairment, as defined by an eGFR of <60 mL/min/1.73m2 and ≥15 mL/min/1.73m2 (using the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation; National Kidney Foundation 2022).
5. Has adequately controlled blood pressure with stable antihypertensive therapy at trial inclusion.
6. Is insulin-naïve, except for short use of insulin not exceeding 15 days during the last year before the screening period.
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Currently Enrolling Clinical Trials
ENDOMETRIOSIS PAIN – Organon - A Phase 2a/b, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter, Clinical Study to Evaluate the Efficacy and Safety of OG-6219 in 3 Dose Levels, in Women 18 to 49 Years of Age with Moderate to Severe Endometriosis-related Pain
1. Pre-menopausal females* of age 18 to 49 years old (inclusive).
2. Surgically (laparoscopy or laparotomy) diagnosed with endometriosis within the last 4 months to 10 years prior to Screening Visit (V1), as documented by medical records.
3. Has moderate to severe endometriosis-related pelvic pain in recent menstrual cycle(s) using a cutoff score of ≥4 in a numeric rating scale (NRS) and likely meets eligibility criterion # 10 at Randomization Visit (V4).
4. Has had spontaneous (ie, without hormonal therapy), regular, menstrual cycles with a cycle length between 21 to 32 days (inclusive) for the past 2 months before V1.
5. Is not expected to undergo a planned gynecological surgery or other surgical procedures for treatment of endometriosis during study participation.
6. Has a normal breast examination at V1. In participants of ≥40 years mammography or contrast-enhanced breast MRI performed within the last 12 months prior to Screening (V1) without clinically significant abnormal findings.
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Female Trials
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Male Trials
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Male & Female Trials