Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants With or Without T2D
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAlveus Therapeutics, Inc.
About this trial
A Study of ALV-100 to Assess Safety, Tolerability, and PK/PD in Overweight/Obese Participants with or without Type 2 Diabetes
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult male and female participants, aged 18 to 65 years, inclusive, at the time of signing the informed consent form
Body mass index between 27.0 to 39.9 kg/m2 at Screening, both inclusive; overweight should be due to excess adipose tissue, as judged by the Investigator.
Have a stable body weight (< 5.0 kg/11 lbs self-reported change) within 90 days prior to Screening
Females must be surgically sterile (by means of bilateral salpingectomy, hysterectomy or bilateral oophorectomy) or be post-menopausal (defined as spontaneous cessation of menses for at least 1 year prior to Screening). Females who are post-menopausal and < 55 years must have a follicle-stimulating hormone level > 40 IU/L at Screening.
Disqualifiers
History or presence of any clinically relevant respiratory, metabolic (including dyslipidemia, however screening total cholesterol below or equal to 302 mg/dL (7.8 mmol/L) and/or screening triglyceride below or equal to 500 mg/dL (5.65 mmol/L) is accepted), renal, hepatic, gastrointestinal, endocrinological conditions (except conditions associated with type 2 diabetes in Part B) at the discretion of the Investigator.
Participants with a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 or a personal history of nonfamilial medullary thyroid carcinoma.
Current or history of chronic or acute pancreatitis.
Obesity caused by known endocrinologic disorders (e.g., Cushing syndrome) or monogenetic or syndromic forms of obesity (for example, Melanocortin 4 Receptor deficiency or Prader Willi Syndrome).
Trial design
Design model
Sequential
Treatments tested in this trial
ALV-100
DrugParticipants will receive multiple ascending doses of ALV-100.
Placebo
DrugParticipants will receive placebo matching ALV-100, volume-matched to active dose.
Treatment groups
180 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Part A - Cohort 1 (ALV-100)Experimental treatment 1 intervention
Group B: Part A - Cohort 1 (Placebo)Placebo comparator 1 intervention
Group C: Part A - Cohort 2 (ALV-100)Experimental treatment 1 intervention
Group D: Part A - Cohort 2 (Placebo)Placebo comparator 1 intervention
Group E: Part A - Cohort 3 (ALV-100)Experimental treatment 1 intervention
Group F: Part A - Cohort 3 (Placebo)Placebo comparator 1 intervention
Group G: Part A - Cohort 4 (ALV-100)Experimental treatment 1 intervention
Group H: Part A - Cohort 4 (Placebo)Placebo comparator 1 intervention
Group I: Part B - T2D Cohort (ALV-100)Experimental treatment 1 intervention
Group J: Part B - T2D Cohort (Placebo)Placebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability
Incidence of treatment emergent adverse events (TEAEs)
Time frame
From First Dose to Week 52Secondary outcomes
1
Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - Cmax, MD
Maximum observed serum concentration after multiple doses (MD) (Cmax, MD)
Time frame
From First Dose to Week 522
Pharmacokinetics (PK) of intact ALV-100 and total ALV-100 - AUC(0-τ), MD
Area under the serum concentration-time curve from time zero to τ, where τ is the dosing interval, (AUC(0-τ), MD)
Time frame
From First Dose to Week 523
Pharmacodynamic (PD) impact on body weight
Change from baseline in body weight
Time frame
Baseline, Week 32 and Week 524
Pharmacodynamic (PD) impact on body weight percentage
Change from baseline in body weight percentage
Time frame
Baseline, Week 32 and Week 52Sponsors and contacts
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Source ClinicalTrials.gov