A Phase 1/2 Study to Evaluate ALN-KHK in Overweight to Obese Healthy Volunteers and Obese Patients With T2DM

Phase 2TerminatedNCT05761301

Alnylam Pharmaceuticals49 enrolled

Overview

To evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses of ALN-KHK and to evaluate the safety, tolerability, efficacy, PK and PD of multiple doses of KHK.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

ALN-KHKDRUG

ALN-KHK will be administered by subcutaneous (SC) injection.

PlaceboDRUG

Placebo will be administered by subcutaneous (SC) injection.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Stable euthyroid status (no known changes in thyroid function; stable hormone replacement for at least 4 months) at screening * Part A: body mass index (BMI) ≥27 kg/m\^2 and ≤34.9 kg/m\^2 * Part B: BMI ≥30 kg/m\^2 to ≤39.9 kg/m\^2, confirmed diagnosis of T2DM, and an HbA1c ≥7.5% to \<10% * Part B: Confirmed T2DM diagnosis Exclusion Criteria: * Parts A and B: has received an investigational agent within the last 30 days * Part A: History of Type 1 or Type 2 diabetes * Part B: History of Type 1 diabetes

Locations (15)

Clinical Trial Site

Phoenix, Arizona, United States

Clinical Trial Site

Vista, California, United States

Clinical Trial Site

Lake Worth, Florida, United States

Outcomes

Primary Outcomes

Part A: Frequency of Adverse Events

Time frame: Up to 9 Months

Part B: Frequency of Adverse Events

Time frame: Up to 12 Months

Secondary Outcomes

Part A: Area Under the Concentration-time Curve (AUC) of ALN-KHK and Potential Major Metabolite(s)

Time frame: Up to 2 Days following dosing on Day 1

Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-KHK and Potential Major Metabolite(s)

Time frame: Up to 2 Days following dosing on Day 1

Part A: Time to Maximum Observed Plasma Concentration (Tmax) of ALN-KHK and Potential Major Metabolite(s)

Time frame: Up to 2 Days following dosing on Day 1

Part A: Fraction of ALN-KHK Excreted in the Urine (fe) and Potential Major Metabolite(s)

Time frame: Postdose on Day 1

Part A: Percent Change from Baseline in Circulating Fructose in Response to a Fructose Tolerance Test

Time frame: Baseline up to Month 6

Part A: Percent Change from Baseline in Urinary Fructose in Response to a Fructose Tolerance Test

Time frame: Baseline up to Month 6

Part A: Percent Change from Baseline in Circulating Fibroblast Growth Factor 21 (FGF21) in Response to a Fructose Tolerance Test

Time frame: Baseline up to Month 6

Part B: Absolute Change from Baseline in Hemoglobin A1C (HbA1c) at 6 Months

Data from ClinicalTrials.gov

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